QC Document Reviewer – Pharma
- Have a strong understanding of common data integrity violations in the Quality Control Laboratory. This knowledge is crucial for success in this role.
- Stay updated on publications from organizations like USP, EU, FDA, and others, including those related to ISO 17025:2017 accreditation. This is to ensure compliance in areas such as analytical applications, release specifications, and documentation practices in the Quality Control Department.
- Timely review of data reports generated within the Quality Control Department, Contract Laboratory reports, and Quality Control Certificates of Analysts using electronic signature. This may also involve reviewing data packets associated with Method Validation or Method Development, as well as reviewing Certificates of Analysis produced after data review.
- Assist in reviewing and documenting Out-of-Specification and Out-of-Trend investigations conducted in the QC laboratory, including Contract Laboratory investigations. Ensure investigations are initiated promptly and review of data is completed in a timely manner for all stages of the investigation.
- Collaborate with laboratory personnel in initiating investigation discussions and participate in diagnostic discussions before re-testing begins.
- Receive training on relevant test methods before reviewing data reports.
- Review data associated with Special Request samples.
Must have 1 - 3 years of experience working in a cGMP environment. Effective interpersonal and self-motivation skills are required, along with the ability to interact with personnel at all levels. Must be able to communicate effectively with other departments and work well in a team environment. Prior knowledge of data integrity violations in the Quality Control Laboratory is preferred.
Education and Experience:
Completed Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in a science-related field, such as Chemistry, Biochemistry, or Biology.