Registered Nurse - Emergency Department - Full Time

Description Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects of a situation. Provides routine and complex care, with the ability to on long-range goals or plans. Continues to develop the ability to cope with and manage contingencies of clinical nursing. Makes appropriate assignments and delegates to other care providers as a means to help manage the clinical situation. Responsibilities: Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders. Consistent with the ANA Scope and Standards of Practice, provides nursing care utilizing the nursing process, including assessment, diagnosis, planning, intervention and evaluation for assigned patients. Addresses increasingly complex psychological, emotional, cultural, and social needs of patient and families in accordance with their level of practice. Using the appropriate protocol, administers medications and treatments; monitors for side-effects and effectiveness of the treatment prescribed. Documents patient history, symptoms, medication, and care given. Assess learning needs and provides education to patients, family members and/or care givers; identify issues and resources. Job Requirements: Education/Skills Bachelor of Science Degree in Nursing, preferred Experience 1 year of experience in the related nursing specialty preferred Licenses, Registrations, or Certifications BLS required RN License in state of employment or compact Position Requirements: Education/Skills All newly hired experienced RNs must attend New Nurses Orientation within the first 30 days of hire. New hires are precepted by a designated trained staff member and initial on-boarding requirements are validated through successful completion of the designated organizational entry competency validation and an Emergency Department- specific competency validation. All newly licensed RNs may participate in a residency program or other specific orientation. Skills completion and competency completion will be achieved with the preceptor at the bedside and documented through the program’s tracking software. Completion of all annual competency verification requirements. Experience One year of experience in a related nursing specialty preferred. Licenses, Registrations, or Certifications Current ACLS certification required Current PALS certification required Current TNCC certification required In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain required certifications for their respective positions within the designated time frame. Credential Grace Periods: If additional credentials are required per the Position Requirements section, a grace period to obtain the certification will apply, dependent on your experience level. Any Candidate/Associate with at least one year of acute care clinical experience in a similar service line within the past three years is considered an Experienced Associate. Any Candidate/Associate who does not have at least one year of full-time acute care clinical experience in the same service line within the past three years is considered an Experienced Associate New to the Specialty. CredentialGrace Periods for Experienced Associates Grace Periods for New Graduates & Experienced Associates New to the Specialty Basic Life Support (BLS)No grace period. AHA or Red Cross accepted at time of hire.No grace period. AHA or Red Cross accepted at time of hire.Advanced Cardiac Life Support (ACLS)Within 30 days of hire.Within 90 days of hire.Pediatric Life Support (PALS)Within 30 days of hire.Within 90 days of hire.Trauma Nurse Core Curriculum (TNCC)Within 60 days of hire.Within 18 months of hire.Trauma Care After Resuscitation (TCAR)Within 60 days of hire.Within 18 months of hire.Neonatal Resuscitation Program (NRP)Within 30 days of hire.Within 60 days of hire.AWHONN INTERMEDIATE FHM (Fetal Heart Monitoring)Within 30 days of hire.Within 60 days of hire.STABLE (Neonatal Education)Within 30 days of hire.Within 60 days of hire. Work Schedule: 7AM - 7PM Work Type: Full Time

Nurse Extern I - Acute MedSurgical A

Description Summary: The Nurse Extern is qualified to attend to the needs of the Patient area, performing duties as indicated by the responsibilities outlined in this job description under the direct supervision of the unit charge person. The Nurse Extern is trained in the delivery of age appropriate care by hospital policy. He or she performs assigned tasks in accordance with the hospital’s philosophy, values, standards, policies and procedures. Responsibilities: ASSISTS NURSING IN CARRYING OUT THE NURSING PLAN OF CARE. Vital signs are completed and reported to nursing within 1 hour of scheduled time. I/O’s are collected and reported to nursing 30 minutes prior to end of shift. All assigned baths are completed within the shift assigned. Notifies nurse of any significant changes in patient condition promptly. Ambulates and assists patient with ADLs within assigned time frame. Monitors for signs of skin breakdown and communicates to nursing staff when indicated. Obtain and record patient weight and height as indicated. Keep patient bed low, locked and side rails up when patient is in bed. Check patient food trays for accuracy. Prepare patient’s environment for eating. Assists the patient in preparation to eat their meal, ie. sitting up in bed or chair, washing the patient’s hands, cleaning the bedside table. Reports patient’s intake to nurse. Assists patient with feeding as necessary. HELPS TO PROMOTE STEWARDSHIP OF RESOURCES AND ENVIRONMENT OF CARE. Returns all equipment to SPD ASAP and at least by the end of the shift. Assist with the monitoring of refrigerator / freezer logs. Cleans refrigerator, microwave and other areas when indicated. Maintains the integrity of the PYXIS Machine and inventory through pushing the “take” button. Is respectful of linen supplies and mindful of appropriate usage of pads, etc. Protects the environment of the patient care area as well as the hospital campus from vandalism and liter. SERVICE EXCELLENCE Consistently uses appropriate “scripting” as instructed when communicating with patients and their families. Models service excellence in caring for patients providing “above and beyond” service consistently exceeding patients and families expectations. Strives to anticipate the needs of patients and takes initiative to meet / exceed the patient’s needs or wishes. Responds to call light promptly. Acts as a “team player” assisting co-workers regularly when time permits. PERFORMS CLERICAL DUTIES RELATED TO PROCEDURES, AS IT RELATES TO A PATIENT CARE UNIT. Checks food trays within 10 minutes of arrival to floor. (If appropriate for unit.) Ensures that all charts are supplied with appropriate forms for documentation. Relays messages to appropriate caregiver within 5-10 minutes of receiving message. Prioritizes orders in the order entry system in a timely and accurate manner. All reports are posted in a timely and accurate manner. Ensures that diet/tube feeding changes are completed and credited every shift. ASSISTS NURSING IN CARRYING OUT THE NURSING PLAN OF CARE Assist the nurse with patient assessment rounds. Collect and label voided urine, sputum and stool specimens. Remove urinary catheters and cleanse catheter site. Assist the nurse with wound care and dressing changes. Perform glucose checks utilizing unit glucose monitors. Perform secretarial duties such as taking off orders and answering call lights. Document I/O’s and vital signs using the computer charting system. Requirements: Must have Completed fundamentals in nursing Current BLS Certification Work Schedule: 7AM - 7PM Work Type: Per Diem As Needed

Nurse Extern I - Acute MedSurgical B

Description Summary: This position provides the student nurse an opportunity to work under the direction of a registered nurse and to gain experience in the areas of nursing professional, nursing processes and nursing practice. This hands-on experience will include educational sessions, job shadow, assist in patient care. May provide patient care in a CNA role as approved by manager (see CNA position description). Responsibilities: ASSISTS NURSING IN CARRYING OUT THE NURSING PLAN OF CARE. Vital signs are completed and reported to nursing within 1 hour of scheduled time. I/O’s are collected and reported to nursing 30 minutes prior to end of shift. All assigned baths are completed within the shift assigned. Notifies nurse of any significant changes in patient condition promptly. Ambulates and assists patient with ADLs within assigned time frame. Monitors for signs of skin breakdown and communicates to nursing staff when indicated. Obtain and record patient weight and height as indicated. Keep patient bed low, locked and side rails up when patient is in bed. Check patient food trays for accuracy. Prepare patient’s environment for eating. Assists the patient in preparation to eat their meal, ie. sitting up in bed or chair, washing the patient’s hands, cleaning the bedside table. Reports patient’s intake to nurse. Assists patient with feeding as necessary. HELPS TO PROMOTE STEWARDSHIP OF RESOURCES AND ENVIRONMENT OF CARE. Returns all equipment to SPD ASAP and at least by the end of the shift. Assist with the monitoring of refrigerator / freezer logs. Cleans refrigerator, microwave and other areas when indicated. Maintains the integrity of the PYXIS Machine and inventory through pushing the “take” button. Is respectful of linen supplies and mindful of appropriate usage of pads, etc. Protects the environment of the patient care area as well as the hospital campus from vandalism and liter. SERVICE EXCELLENCE Consistently uses appropriate “scripting” as instructed when communicating with patients and their families. Models service excellence in caring for patients providing “above and beyond” service consistently exceeding patients and families expectations. Strives to anticipate the needs of patients and takes initiative to meet / exceed the patient’s needs or wishes. Responds to call light promptly. Acts as a “team player” assisting co-workers regularly when time permits. PERFORMS CLERICAL DUTIES RELATED TO PROCEDURES, AS IT RELATES TO A PATIENT CARE UNIT. Checks food trays within 10 minutes of arrival to floor. (If appropriate for unit.) Ensures that all charts are supplied with appropriate forms for documentation. Relays messages to appropriate caregiver within 5-10 minutes of receiving message. Prioritizes orders in the order entry system in a timely and accurate manner. All reports are posted in a timely and accurate manner. Ensures that diet/tube feeding changes are completed and credited every shift. ASSISTS NURSING IN CARRYING OUT THE NURSING PLAN OF CARE Assist the nurse with patient assessment rounds. Collect and label voided urine, sputum and stool specimens. Remove urinary catheters and cleanse catheter site. Assist the nurse with wound care and dressing changes. Perform glucose checks utilizing unit glucose monitors. Perform secretarial duties such as taking off orders and answering call lights. Document I/O’s and vital signs using the computer charting system. Requirements: Must have completed fundamentals in nursing Current CPR Certification Requirements: Associate's Degree in Nursing required BLS required Work Schedule: PRN Work Type: Per Diem As Needed

Registered Nurse-Ambulatory Surgery Center Kerrville

Description Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects of a situation. Provides routine and complex care, with the ability to on long-range goals or plans. Continues to develop the ability to cope with and manage contingencies of clinical nursing. Makes appropriate assignments and delegates to other care providers as a means to help manage the clinical situation. Responsibilities: Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders. Consistent with the ANA Scope and Standards of Practice, provides nursing care utilizing the nursing process, including assessment, diagnosis, planning, intervention and evaluation for assigned patients. Addresses increasingly complex psychological, emotional, cultural, and social needs of patient and families in accordance with their level of practice. Using the appropriate protocol, administers medications and treatments; monitors for side-effects and effectiveness of the treatment prescribed. Documents patient history, symptoms, medication, and care given. Assess learning needs and provides education to patients, family members and/or care givers; identify issues and resources. Job Requirements: Education/Skills Bachelor of Science Degree in Nursing, preferred Experience 1 year of experience in the related nursing specialty preferred Licenses, Registrations, or Certifications BLS required RN License in state of employment or compact Work Type: Part Time

Registered Nurse OR Circulator Ambulatory Surgery Center Kerrville

Description Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects of a situation. Provides routine and complex care, with the ability to on long-range goals or plans. Continues to develop the ability to cope with and manage contingencies of clinical nursing. Makes appropriate assignments and delegates to other care providers as a means to help manage the clinical situation. Responsibilities: Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders. Consistent with the ANA Scope and Standards of Practice, provides nursing care utilizing the nursing process, including assessment, diagnosis, planning, intervention and evaluation for assigned patients. Addresses increasingly complex psychological, emotional, cultural, and social needs of patient and families in accordance with their level of practice. Using the appropriate protocol, administers medications and treatments; monitors for side-effects and effectiveness of the treatment prescribed. Documents patient history, symptoms, medication, and care given. Assess learning needs and provides education to patients, family members and/or care givers; identify issues and resources. Job Requirements: Education/Skills Bachelor of Science Degree in Nursing, preferred Experience 1 year of experience in the related nursing specialty preferred Licenses, Registrations, or Certifications BLS required RN License in state of employment or compact Work Type: Per Diem as Needed

Nurse Extern I - Acute MedSurgical A

Description Summary: This position provides the student nurse an opportunity to work under the direction of a registered nurse and to gain experience in the areas of nursing professional, nursing processes and nursing practice. This hands-on experience will include educational sessions, job shadow, assist in patient care. May provide patient care in a CNA role as approved by manager (see CNA position description). Responsibilities: ASSISTS NURSING IN CARRYING OUT THE NURSING PLAN OF CARE. Vital signs are completed and reported to nursing within 1 hour of scheduled time. I/O’s are collected and reported to nursing 30 minutes prior to end of shift. All assigned baths are completed within the shift assigned. Notifies nurse of any significant changes in patient condition promptly. Ambulates and assists patient with ADLs within assigned time frame. Monitors for signs of skin breakdown and communicates to nursing staff when indicated. Obtain and record patient weight and height as indicated. Keep patient bed low, locked and side rails up when patient is in bed. Check patient food trays for accuracy. Prepare patient’s environment for eating. Assists the patient in preparation to eat their meal, ie. sitting up in bed or chair, washing the patient’s hands, cleaning the bedside table. Reports patient’s intake to nurse. Assists patient with feeding as necessary. HELPS TO PROMOTE STEWARDSHIP OF RESOURCES AND ENVIRONMENT OF CARE. Returns all equipment to SPD ASAP and at least by the end of the shift. Assist with the monitoring of refrigerator / freezer logs. Cleans refrigerator, microwave and other areas when indicated. Maintains the integrity of the PYXIS Machine and inventory through pushing the “take” button. Is respectful of linen supplies and mindful of appropriate usage of pads, etc. Protects the environment of the patient care area as well as the hospital campus from vandalism and liter. SERVICE EXCELLENCE Consistently uses appropriate “scripting” as instructed when communicating with patients and their families. Models service excellence in caring for patients providing “above and beyond” service consistently exceeding patients and families expectations. Strives to anticipate the needs of patients and takes initiative to meet / exceed the patient’s needs or wishes. Responds to call light promptly. Acts as a “team player” assisting co-workers regularly when time permits. PERFORMS CLERICAL DUTIES RELATED TO PROCEDURES, AS IT RELATES TO A PATIENT CARE UNIT. Checks food trays within 10 minutes of arrival to floor. (If appropriate for unit.) Ensures that all charts are supplied with appropriate forms for documentation. Relays messages to appropriate caregiver within 5-10 minutes of receiving message. Prioritizes orders in the order entry system in a timely and accurate manner. All reports are posted in a timely and accurate manner. Ensures that diet/tube feeding changes are completed and credited every shift. ASSISTS NURSING IN CARRYING OUT THE NURSING PLAN OF CARE Assist the nurse with patient assessment rounds. Collect and label voided urine, sputum and stool specimens. Remove urinary catheters and cleanse catheter site. Assist the nurse with wound care and dressing changes. Perform glucose checks utilizing unit glucose monitors. Perform secretarial duties such as taking off orders and answering call lights. Document I/O’s and vital signs using the computer charting system. Requirements: Must have Completed fundamentals in nursing Current CPR Certification Requirements: Associate's Degree in Nursing BLS Work Schedule: PRN Work Type: Per Diem As Needed

RN, Registered Nurse - A3 – Cardiac ICU / CCU

Description A3 is a 24-bed unit providing high-acuity care for cardiac and medical-surgical patients with various co-morbidities. We care for post-cardiac intervention patients (e.g., heart catheterizations, AAA stent repairs, TAVRs, EP ablations, pacemaker/ICD placements) and manage specialized devices like Impellas and IABPs, Artic Sun and Tablo XT. We also treat ventilator-dependent patients and those with conditions like hypertension, diabetes, GI bleeds, peripheral vascular disease and renal disease. The unit handles multiple infusions for blood pressure, cardiac issues, thrombolytics, sedation and paralytics, as well as post-surgical ICU care. Our goal is to deliver exceptional, evidence-based care through teamwork and positive outcomes. Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects of a situation. Provides routine and complex care, with the ability to on long-range goals or plans. Continues to develop the ability to cope with and manage contingencies of clinical nursing. Makes appropriate assignments and delegates to other care providers as a means to help manage the clinical situation. Responsibilities: Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders. Consistent with the ANA Scope and Standards of Practice, provides nursing care utilizing the nursing process, including assessment, diagnosis, planning, intervention and evaluation for assigned patients. Addresses increasingly complex psychological, emotional, cultural, and social needs of patient and families in accordance with their level of practice. Using the appropriate protocol, administers medications and treatments; monitors for side-effects and effectiveness of the treatment prescribed. Documents patient history, symptoms, medication, and care given. Assess learning needs and provides education to patients, family members and/or care givers; identify issues and resources. Job Requirements: Education/Skills Bachelor of Science Degree in Nursing, preferred Experience 1 year of experience in the related nursing specialty preferred Licenses, Registrations, or Certifications BLS required RN License in state of employment or compact Position Requirements: Education/Skills All newly hired experienced RNs must attend New Nurses Orientation within the first 30 days of hire. New hires are precepted by a designated trained staff member and initial on-boarding requirements are validated through successful completion of the designated organizational entry competency validation and a Critical Care Department-specific competency validation. Completion of all annual competency verification requirements. Experience One year of experience in Critical Care setting preferred but will accept new graduates. Licenses, Registrations, or Certifications Current ACLS certification required In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain required certifications for their respective positions within the designated time frame. Credential Grace Periods: If additional credentials are required per the Position Requirements section, a grace period to obtain the certification will apply, dependent on your experience level. Any Candidate/Associate with at least one year of acute care clinical experience in a similar service line within the past three years is considered an Experienced Associate. Any Candidate/Associate who does not have at least one year of full-time acute care clinical experience in the same service line within the past three years is considered an Experienced Associate New to the Specialty. CredentialGrace Periods for Experienced Associates Grace Periods for New Graduates & Experienced Associates New to the Specialty Basic Life Support (BLS)No grace period. AHA or Red Cross accepted at time of hire.No grace period. AHA or Red Cross accepted at time of hire.Advanced Cardiac Life Support (ACLS)Within 30 days of hire.Within 90 days of hire.Pediatric Life Support (PALS)Within 30 days of hire.Within 90 days of hire.Trauma Nurse Core Curriculum (TNCC)Within 60 days of hire.Within 18 months of hire.Trauma Care After Resuscitation (TCAR)Within 60 days of hire.Within 18 months of hire.Neonatal Resuscitation Program (NRP)Within 30 days of hire.Within 60 days of hire.AWHONN INTERMEDIATE FHM (Fetal Heart Monitoring)Within 30 days of hire.Within 60 days of hire.STABLE (Neonatal Education)Within 30 days of hire.Within 60 days of hire. Work Schedule: 7PM - 7AM Work Type: Full Time

RN, Registered Nurse - Emergency Room

Description Summary: The competent Nurse, in the same or similar clinical setting, practices independently and demonstrates an awareness of all relevant aspects of a situation. Provides routine and complex care, with the ability to on long-range goals or plans. Continues to develop the ability to cope with and manage contingencies of clinical nursing. Makes appropriate assignments and delegates to other care providers as a means to help manage the clinical situation. Responsibilities: Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders. Consistent with the ANA Scope and Standards of Practice, provides nursing care utilizing the nursing process, including assessment, diagnosis, planning, intervention and evaluation for assigned patients. Addresses increasingly complex psychological, emotional, cultural, and social needs of patient and families in accordance with their level of practice. Using the appropriate protocol, administers medications and treatments; monitors for side-effects and effectiveness of the treatment prescribed. Documents patient history, symptoms, medication, and care given. Assess learning needs and provides education to patients, family members and/or care givers; identify issues and resources. Job Requirements: Education/Skills Bachelor of Science Degree in Nursing, preferred Experience 1 year of experience in the related nursing specialty preferred Licenses, Registrations, or Certifications BLS required RN License in state of employment or compact Position Requirements: Education/Skills All newly hired experienced RNs must attend New Nurses Orientation within the first 30 days of hire. New hires are precepted by a designated trained staff member and initial on-boarding requirements are validated through successful completion of the designated organizational entry competency validation and an Emergency Department- specific competency validation. All newly licensed RNs may participate in a residency program or other specific orientation. Skills completion and competency completion will be achieved with the preceptor at the bedside and documented through the program’s tracking software. Completion of all annual competency verification requirements. Experience One year of experience in a related nursing specialty preferred. Licenses, Registrations, or Certifications Current ACLS certification required Current PALS certification required Current TNCC certification required In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain required certifications for their respective positions within the designated time frame. Credential Grace Periods: If additional credentials are required per the Position Requirements section, a grace period to obtain the certification will apply, dependent on your experience level. Any Candidate/Associate with at least one year of acute care clinical experience in a similar service line within the past three years is considered an Experienced Associate. Any Candidate/Associate who does not have at least one year of full-time acute care clinical experience in the same service line within the past three years is considered an Experienced Associate New to the Specialty. CredentialGrace Periods for Experienced Associates Grace Periods for New Graduates & Experienced Associates New to the Specialty Basic Life Support (BLS)No grace period. AHA or Red Cross accepted at time of hire.No grace period. AHA or Red Cross accepted at time of hire.Advanced Cardiac Life Support (ACLS)Within 30 days of hire.Within 90 days of hire.Pediatric Life Support (PALS)Within 30 days of hire.Within 90 days of hire.Trauma Nurse Core Curriculum (TNCC)Within 60 days of hire.Within 18 months of hire.Trauma Care After Resuscitation (TCAR)Within 60 days of hire.Within 18 months of hire.Neonatal Resuscitation Program (NRP)Within 30 days of hire.Within 60 days of hire.AWHONN INTERMEDIATE FHM (Fetal Heart Monitoring)Within 30 days of hire.Within 60 days of hire.STABLE (Neonatal Education)Within 30 days of hire.Within 60 days of hire. Work Schedule: Mid Shift Work Type: Full Time

Project Manager

Accentuate Staffing is partnering with a specialized power systems integrator that supports high-profile federal and mission-critical infrastructure projects. They are hiring a Project Manager to lead complex electrical installation projects across the U.S. This is a direct hire opportunity offering competitive compensation, strong benefits, and the chance to work on nationally significant facilities. The ideal candidate has experience managing electrical construction projects, working with standby or critical power, and coordinating subcontracted trades. Responsibilities Manage multiple electrical power system installation projects from kickoff through closeout. Develop schedules, budgets, submittals, and resource plans while maintaining client communication. Lead cross-functional teams of engineers, field personnel, and subcontractors. Ensure compliance with safety standards, federal requirements, and quality expectations. Review and approve invoices, track project costs, and support financial reporting. Coordinate permitting, inspections, and material/equipment procurement. Identify project risks and implement mitigation strategies to protect schedule and budget. Requirements Background in electrical contracting or overall commercial/industrial construction. Experience in environments such as airports, federal facilities, hospitals, pharma, or data centers. Familiarity with mission critical systems, standby power, generators, or battery/UPS systems. Ability to travel approximately 20% (roughly monthly trips). Experience managing subcontractors and field installation teams. Knowledge of NEC, OSHA, UL, or similar regulatory standards. Ability to pass a federal background check.

Quality Manager, Partners

Job Description | Quality Manager, Partners Title | Quality Manager, Partners Location | Hybrid (Totowa, NJ) Department | Quality/Regulatory/EH&S Reports To | Director, Quality Management, Partners & Training Overview SOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This role supports the Director, Quality Assurance, Partners & Training, and provides Quality leadership to the Radiopharmaceutical Contract Manufacturing (RCM) division throughout the SOFIE network. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This person will play an active and integral part of the Quality team supporting compliance, improvement, and implementation with all RCM products at all SOFIE facilities. Essential Duties and Responsibilities ▪ Provide quality assurance support to the Radiopharmaceutical Contract Manufacturing (RCM) group within the SOFIE Network. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products. ▪ Be a quality liaison, develop solid relationships, and establish open communication with SOFIE partners and sponsors. ▪ Assist in the roll-out of new products at SOFIE network sites. ▪ Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 211 and 212 requirements, and continuing to establish an effective and efficient quality management system at one SOFIE facility, at minimum, and companywide. ▪ Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System (QMS). ▪ Assist Director, RCM, Directors, Quality Management, Directors, QA and Regional Managers, QA with quality initiatives, decisions, and training, etc. ▪ Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA when necessary. Closely track and follow-up on these activities for timely closure. Ensure that scientifically sound investigations are conducted, and root causes are identified. Initiate and implement CAPA plans. Evaluate effectiveness of the CAPA plans through reporting and trending. ▪ Author and review cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents. ▪ Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions. ▪ Assist with the ongoing training program and present training presentations on applicable job-related procedures and topics. ▪ Identify non-compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site and corporate level and resolve quality related issues. ▪ Initiate action plans to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements. ▪ Liaise with corporate QA for audits, customer audits, partner audits, and regulatory agency audits. Perform readiness assessment and take corrective actions as needed prior to the audits. Summarize and report auditing progresses daily during each audit. Prepare complete responses to the audit outcomes on time. Ensure corrective actions being implemented according to the committed timelines. ▪ Review partner customer/patient complaints to determine the possible root causes. Work with the partners and customers to ensure their concerns are addressed, quality standards are met, and issues are resolved promptly and effectively. ▪ Maintain knowledge of current regulations and quality policies. Attend quality related meetings and conference calls. Interface with corporate QA on quality related issues. Provide quality status updates as required by corporate QA. ▪ Be a Subject Matter Expert resource for the entire network for the key area: Radiopharmaceutical Contract Manufacturing (RCM). \ ▪ Author or review certain sections of regulatory submissions, including responses to regulatory inquiries as needed. ▪ Perform other tasks as required. Qualifications ▪ Bachelor of Science Degree (B.Sc.) in an appropriate scientific subject, e.g., Chemistry, Microbiology, Quality and Regulatory Affairs, Regulatory Science, etc. preferred but will entertain applicants with relevant education and work experience. ▪ 2 years of work experience in Quality Assurance or Regulatory Affairs in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred. ▪ 1 years’ supervisory experience within a Quality Assurance or Quality Control function preferred. ▪ Experience with FDA regulatory submissions (establishment registration, safety reports, annual reports, amendments, etc.) preferred. ▪ Familiarity with radiopharmaceutical manufacturing processes and related QC release testing preferred. ▪ Working knowledge of US and ICH cGMP regulations and guidelines, risk management standards, quality attributes, and Quality Assurance best practices in the pharmaceutical industry required. ▪ Experience leading internal audits preferred. ▪ Knowledge of current FDA enforcement issues preferred. ▪ Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision required. ▪ Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, and regulatory agencies required. ▪ Ability to prepare and present written and verbal reports to upper management required. ▪ Ability to project manage and have excellent organization and prioritization skills. ▪ Travel: up to 50% domestically.