Quality Assurance Validation Specialist
ApTask Global Workforce (AGW) is seeking a Specialist Quality Assurance for a 12 month contract position with a Biotechnology company located in Holly Springs, NC. Summary: The Quality Assurance Validation Specialist will provide quality support and oversight of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. They will collaborate cross-functionally to ensure project timelines and milestones are met. This is a fully onsite position that requires the ability to gown in and/or wear construction gear and steel toe boots. Responsibilities: Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for the site, including facilities/utilities, equipment/systems, computerized systems, process, and validation maintenance. Perform quality review of documents to support facility commissioning and qualification, according to project timelines, including Commissioning/Qualification Protocols, Performance Qualification Protocols (PQ), and Final Reports. Review and approve protocol discrepancies. Provide quality support during the execution of commissioning and qualification testing, reviewing and approving changes and discrepancies as required. Ensure that all activities and related documentation for facilities, equipment, materials, and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Safety, and Controls. Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies. Participate in meetings related to document planning, execution, and issue resolution. Escalate any compliance concerns or critical gaps to QA management. Requirements: Candidates must meet one of the following education and experience requirements: Doctorate degree Master's degree and 3 years of experience Bachelor's degree and 5 years of experience Associate's degree and 10 years of experience High school diploma / GED and 12 years of experience Understanding of regulatory requirements, trends, and industry standards. Experience/knowledge in commissioning/qualification/validation, including computer-systems validation. Excellent written and verbal communication skills. Ability to work in a team matrix environment and build relationships with partners. Great attention to detail and high degree of accuracy in task execution and GMP documentation. Ability to complete tasks autonomously, providing updates to senior management, identifying potential issues, and following assignments through to completion. Proven capability and experience applying GMP requirements in an operational and Quality Control setting. Ability to be fully onsite and able to gown in, and/or wear construction gear and steel toe boots. Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. Pay rate: is up to $37.96 per hour. If you have the described qualifications and are interested in this exciting opportunity, please apply! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery. Benefits of working with ApTask Global Workforce include: Medical Dental Vision Sick Pay (for applicable states/municipalities) Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/ . ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran
