Quality Assurance Specialist

Quality Assurance SpecialistJohnson Service Group (JSG) is seeking a Quality Assurance Specialist for our CMO life sciences client in Carlsbad, CA. We are seeking an experienced Quality Assurance Specialist to support quality and compliance activities within a regulated life sciences manufacturing environment. This position will play an important role in batch record review and lot release, quality investigations, client complaints, CAPAs, non-conformances, and manufacturing support. The ideal candidate has hands-on experience in a cGMP-regulated pharmaceutical, biotech, medical device, or life sciences manufacturing environment and is comfortable working cross-functionally to resolve quality and compliance issues.Responsibilities:Review production batch records and supporting documentation for lot disposition and releasePrepare Certificates of Compliance (COC) and review Certificates of Analysis (COA) as requiredPerform line clearance activities for cGMP manufacturing processesSupport manufacturing teams with product quality and compliance issuesInitiate, lead, and support investigations involving deviations, non-conformances, CAPAs, and customer/client complaintsManage client complaints through investigation and resolutionPerform visual inspection of finished productsSupport root cause analysis and continuous improvement initiativesConduct facility walkthroughs to ensure cleanrooms, laboratories, warehouse areas, and other controlled spaces remain compliantOversee facility and cleanroom cleaning compliance, including required training documentation, cleaning forms, and gowning requalificationMaintain accurate documentation in accordance with cGMP and Good Documentation Practices (GDP)Qualifications:Bachelor's degree in a Life Sciences discipline or related field preferredMinimum 4 years of relevant Quality Assurance experienceExperience within life sciences, pharmaceutical, biotech, medical device, or other regulated manufacturingWorking knowledge of cGMP, 21 CFR 820, ISO 13485, and Good Documentation PracticesExperience with quality investigations, deviations/non-conformances, CAPAs, and complaint managementExperience reviewing batch records and manufacturing documentationStrong problem-solving skills with the ability to make sound quality decisions regarding products and materialsExcellent attention to detail and organizational skillsAbility to manage multiple priorities in a deadline-driven environmentStrong written and verbal communication skills with the ability to work effectively across departmentsAbility to work independently with minimal directionExperience with MasterControl and/or NetSuite is a plusJohnson 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. JSG (Johnson Service Group, Inc.)