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Quality System Specialist at BioTalent Quality System Specialist at BioTalent in Aliso Viejo, California Posted in 2 days ago.

Type:

full-time

Job Description:

???? Senior Specialist, Quality Systems ???? Tustin, CA | ???? Full-Time | ???? Monday-Friday ???? Help Ensure Quality in Life-Saving Biopharmaceuticals Are you passionate about Quality Systems , CAPAs, deviations, GMP compliance, and documentation excellence? We're looking for a Senior Specialist, Quality Systems to join a growing biopharmaceutical team supporting innovative biologic therapies. If you thrive in a fast-paced quality environment and enjoy working with deviation investigations, CAPAs, quality documentation, and inspection readiness , this could be your next opportunity. ???? What You'll Do ? Review, edit, and approve deviation reports, calibration exceptions, OOS, and OOL investigations ? Support CAPA authoring, review, and approval activities ? Prepare and review SOPs, forms, batch production records, and controlled documents ? Participate in the generation and revision of quality systems and project documentation ? Support development, validation, and stability documentation activities ? Collaborate with cross-functional teams to resolve quality system issues and discrepancies ? Represent Quality on multidisciplinary project teams ? Provide support to internal and external customers on Quality topics ? Maintain inspection readiness and support audit preparation activities ? Support continuous improvement initiatives and Quality Management System activities ? What We're Looking For ???? B.A. or B.S. degree (preferably in a Life Sciences field) ???? Minimum 4-5 years of experience in the biopharmaceutical industry (preferably with biologics) ???? Hands-on experience or exposure with :

• Quality Systems
• CAPA Management
• Deviations
• OOS Investigations
• OOL Investigations
• GMP Compliance
• Quality Documentation
• SOP Development
• Batch Production Records (BPRs)
• Root Cause Analysis
• Impact Assessments
• Inspection Readiness
• Controlled Documents
• Quality Management Systems (QMS)
• Technical Writing
• Document Management Systems Bonus
• Experience with biologics preferred
• Experience using Quality Management Systems and electronic document management systems
• Strong technical writing and editing skills ?

??? Compensation Range $42.69 - $53.36 per hour (depending on experience and qualifications) Comprehensive Benefits Health, Dental, and Vision Insurance 401(k) Matching Paid Time Off Career Growth Opportunities ???? Please Note ? On-site in Tustin, CA ???? Full-time Monday-Friday, 8:00 AM-5:00 PM schedule ? Overtime and weekend availability may be required ???? No relocation assistance ???? No visa sponsorship available ???????? Applicants must already be authorized to work in the U.S. If this sounds like you-or someone in your network-I'd love to connect! #BiotechJobs #QualitySystems #SeniorSpecialist #QualityAssurance #CAPA #Deviations #OOS #GMP #Biologics #QualityManagement #TechnicalWriting #LifeSciences #Biopharma #Hiring #TustinCA