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BioTalent
Quality System Specialist
Career Insights for Systems Administrator
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Based on California data
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What they do
A Systems Administrator manages the day-to-day operations of an organization's computer networks, including the systems that connect computers and other technology to each other and to outside networks. Installs, organizes, and supports the hardware and software of these systems.
$105,886 / year median in California
-11% projected decline
Job Description
Quality System Specialist at BioTalent Quality System Specialist at BioTalent in Aliso Viejo, California Posted in 2 days ago.
Type:
full-timeJob 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 ?
Benefits
- Paid Time Off (PTO)
- 401(k) Plans
- Health Insurance
- Dental Insurance