QC Analyst - Data Reviewer New

We are currently seeking an experienced QC Data Reviewer to join our client’s Quality Control team. This role plays a crucial part in supporting batch release and stability programs by ensuring data integrity, compliance, and effective interdepartmental collaboration.

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.