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QC Specialist
Katalyst Healthcares & Life Sciences
🇬🇧 United Kingdom | 🇺🇸 United States
On-site
4 months ago
- GMP
- CAPA
4 months ago
Not enough detail in this posting to match
- The Quality Control Technical Transfer Analyst 3 supports the QC department by performing analytical testing, assisting with technical transfer activities, and maintaining quality documentation in a GMP-regulated pharmaceutical or biotechnology environment. The role involves executing laboratory testing, reviewing data, supporting validations and investigations, and ensuring compliance with GMP and Data Integrity requirements.
Roles and Responsibilities
- Perform analytical testing for in-process samples, lot release, and stability studies.
- Support technical transfers, method validations, and laboratory investigations.
- Review analytical data and ensure results meet quality and compliance standards.
- Prepare and maintain quality documentation such as Deviations, CAPA, Change Control, and Investigations.
- Use laboratory systems and software including SoftmaxPro, Empower, SoloVPE, LIMS, and TrackWise.
- Support software validation activities, including writing procedures and executing validation test scripts.
- Apply GMP and Data Integrity principles in all laboratory activities.
- Collaborate with cross-functional teams and provide training when required.
- Perform root cause analysis for laboratory or software-related issues.
Experience
- 3–5 years of experience in a Quality Control laboratory within the pharmaceutical or biotechnology industry.
- Experience working in a GMP-regulated environment.
- Hands-on experience with analytical testing, method transfers, validations, and investigations.
- Experience with quality systems such as Deviations, CAPA, Change Control, and LIMS/TrackWise is preferred.
Education
- Associate's Degree in Microbiology, Biochemistry, Biotechnology, Chemistry, or a related Life Sciences field.
QC Specialist · Katalyst Healthcares & Life Sciences