Quality Assurance Specialist

Job Description 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 clean rooms, 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 with in 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 Master Control and/or Net Suite is a plus
   
   #D800
   
** 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.