Quality Assurance Specialist

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. This position will play an important role in batch record review and lot release, quality investigations, client complaints, CAPAs, non-conformances, and manufacturing support.

Johnson 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 release
• Prepare Certificates of Compliance (COC) and review Certificates of Analysis (COA) as required
• Perform line clearance activities for cGMP manufacturing processes
• Support manufacturing teams with product quality and compliance issues
• Initiate, lead, and support investigations involving deviations, non-conformances, CAPAs, and customer/client complaints
• Manage client complaints through investigation and resolution
• Perform visual inspection of finished products
• Support root cause analysis and continuous improvement initiatives
• Conduct facility walkthroughs to ensure cleanrooms, laboratories, warehouse areas, and other controlled spaces remain compliant
• Oversee facility and cleanroom cleaning compliance, including required training documentation, cleaning forms, and gowning requalification
• Maintain accurate documentation in accordance with cGMP and Good Documentation Practices (GDP)

Qualifications

• Bachelor’s degree in a Life Sciences discipline or related field preferred
• Minimum 4 years of relevant Quality Assurance experience
• Experience within life sciences, pharmaceutical, biotech, medical device, or other regulated manufacturing
• Working knowledge of cGMP, 21 CFR 820, ISO 13485, and Good Documentation Practices
• Experience with quality investigations, deviations/non-conformances, CAPAs, and complaint management
• Experience reviewing batch records and manufacturing documentation
• Strong problem-solving skills with the ability to make sound quality decisions regarding products and materials
• Excellent attention to detail and organizational skills
• Ability to manage multiple priorities in a deadline-driven environment
• Strong written and verbal communication skills with the ability to work effectively across departments
• Ability to work independently with minimal direction
• Experience with MasterControl and/or NetSuite is a plus

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** 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.