Quality Specialist
Job Description Job Description Johnson Service Group (JSG) is seeking a Quality Specialist II (Associate) to support Large Molecule / Biologics Quality Assurance activities. This contractor will help strengthen GMP documentation and training materials supporting biologics/vaccine development and manufacturing operations. The ideal candidate is a senior-level quality professional who can quickly assess existing SOPs, streamline documentation processes, and build clear training content with minimal onboarding. Key Responsibilities Support large molecule development and manufacturing activities in alignment with GMPs , quality standards, and global regulatory expectations Author, review, revise, and streamline SOPs , work instructions, and controlled documents Identify compliance risks , documentation gaps, and improvement opportunities Maintain and organize training curricula to ensure role-based requirements are current and complete Develop simple learning materials and PowerPoint-based training aids Support inspection readiness by ensuring documentation is organized, accurate, and readily retrievable Collaborate primarily with the core stakeholder (Michelle Lutz) and partner with SMEs as needed Required Qualifications Bachelor’s degree in science, engineering, or related discipline (advanced degree preferred) 5 years experience in biologics / large molecule operations Experience in QA, Manufacturing, Technical Operations, or GMP documentation within biologics/vaccines/large molecule environments Strong working knowledge of GMPs and global regulatory expectations Demonstrated experience authoring/reviewing/revising controlled documents and/or training materials Excellent attention to detail, technical writing, organization, and ability to work independently in a matrixed environment Preferred Skills / Nice-to-Haves Experience with deviations, CAPAs, change controls, batch disposition, inspection readiness Experience with document/learning/quality management systems SAP experience (preferred) Experience in sterile manufacturing, clinical supply, or biologics/vaccine environments Ability to appropriately leverage AI tools for training content development Software Skills Strong proficiency in Microsoft PowerPoint (preferred) Microsoft Word, Excel, and Office Suite \nCompany Description Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 40 years of experience investing in people and companies. We offer medical, dental, vision, life insurance options, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law. Company Description Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 40 years of experience investing in people and companies. We offer medical, dental, vision, life insurance options, 401(k), weekly pay, and more.\r\n\r\nJohnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
