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QC Analyst
1 month ago
Key Responsibilities:
- Review laboratory data in a timely manner to support batch release and stability programs.
- Verify results against trend limits and specifications; identify and escalate deviations or lab investigations.
- Conduct trending of data and track the frequency of Not Right First Time (NRFT) events.
- Provide QC and management support, maintaining clear communication across Quality and Production teams.
- Maintain, update, and issue control prints, methods, specifications, and SOPs in line with pharmacopoeial and regulatory requirements.
- Contribute to training of analysts in relevant techniques, SOPs, and updates.
- Ensure documentation and operations meet cGMP and GDP standards in a regulated environment.
Requirements:
- Minimum 3 years of QC or related experience in a regulated GMP environment.
- Empower software experience is essential – must be confident in using Empower for data review.
- High attention to detail and the ability to prioritize tasks to meet tight deadlines.
- Experience in identifying deviations and supporting lab investigations.
- Proficiency in quality systems and good understanding of regulatory compliance.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a collaborative team.
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