QA Specialist
TandymUSA, Ohio, Columbusjob_description.job_card.variable_hours_ago
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job_description.job_card.job_description8+ years of relevant experience in a GMP-regulated environment Bachelor's Degree in a scientific discipline (e.g., Biology, Biochemistry, Biotechnology, Engineering) or equivalent experience Experience with Quality oversight of contract manufacturing organization (CMO) Strong understanding of Cell and Gene Therapy manufacturing processes, including aseptic techniques and plasmid production Experience with risk assessments, batch record review and change control using Veeva / TrackWise Quality System Strong knowledge of root cause analysis (RCA) tools with experience leading complex investigations Familiarity with regulatory requirements (FDA, EMA, ICH) for advanced therapy medicinal products (ATMPs) Excellent communication, organizational, and analytical skills Ability to work independently and collaboratively in a dynamic, fast-paced environment
A pharmaceutical company is actively seeking a new QA Specialist to play a critical role in supporting External Quality Assurance Operations for late-stage programs (gene therapy), ensuring compliance with organization procedures, Quality Agreement, and regulatory requirements.
Responsibilities :
- Review and assess internal and external deviations related to manufacturing, and testing
- Ensure thorough root cause analysis and effective CAPA implementation
- Collaborate with stakeholders to drive timely closure and continuous improvement
- Perform executed batch record review ensuring completeness, accuracy, and compliance with regulatory expectations
- Provide real-time QA support during manufacturing and aseptic processing operations, including oversight of critical steps and data integrity verification
- Review and approve change controls and notifications, ensuring appropriate risk assessments and impact evaluations are conducted
- Ensure changes are implemented in a controlled and compliant manner, aligned with internal program milestones and regulatory commitments
- Partner with Manufacturing, MS&T, QC, Regulatory Affairs, and Supply Chain to ensure alignment on quality expectations and timely issue resolution
- Contribute to the development and refinement of QA procedures, templates, and best practices tailored to support GMP operations
- Identify and implement process improvements to enhance compliance and operational efficiency
Qualifications :
Desired Skills :
Experience with Biologics or Gene Therapy products
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Qa Specialist • USA, Ohio, Columbus