Job Description:
We are currently seeking an experienced Quality Control Data Reviewer to join our team. This role plays a crucial part in supporting batch release and stability programs by ensuring data integrity, compliance, and effective collaboration across departments.
Main Responsibilities:
- Timely review of laboratory data 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 quality and management support, maintaining clear communication across Quality and Production teams.
- Maintain, update, and issue control prints, methods, specifications, and SOPs in line with regulatory requirements.
- Contribute to training of analysts in relevant techniques, SOPs, and updates.
- Ensure documentation and operations meet standards in a regulated environment.
Required Skills and Qualifications:
- Minimum 3 years of QC or related experience in a regulated GMP environment.
- Proficiency in Empower software for data review is essential.
- High attention to detail and ability to prioritize tasks to meet deadlines.
- Experience in identifying deviations and supporting lab investigations.
- Good understanding of regulatory compliance and quality systems.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a collaborative team.