QC Document Reviewer
- The Quality Control Document Analyst (QCDA) must possess a solid understanding of common data integrity violations in the Quality Control Laboratory. This knowledge is crucial for the QCDA to excel in this position.
- The QCDA is responsible for staying up-to-date on publications released by esteemed organizations such as USP, EU, FDA, and others. This includes publications related to ISO 17025:2017 accreditation, ensuring compliance in analytical applications, release specifications, and documentation practices within the Quality Control Department.
- The QCDA will carefully review data reports generated internally by the Quality Control Department, as well as Contract Laboratory reports and Quality Control Certificates of Analysts. This review will be conducted using electronic signatures in a prompt manner. Additionally, the QCDA may also be required to review data packets associated with Method Validation or Method Development, as well as review Certificates of Analysis produced after data review.
- Assisting with the review and composition of Out-of-Specification and Out-of-Trend investigations is another important responsibility of the QCDA. This includes investigations initiated in the QC laboratory and Contract Laboratory investigations. The QCDA will ensure that responsible personnel/contract labs initiate investigations promptly and that data is reviewed within designated timelines for all stages of the investigation.
- Furthermore, the QCDA will play a role in initiating investigation discussions with laboratory personnel and actively participate in diagnostic discussions prior to investigation re-testing.
- Prior to reviewing data reports, the QCDA will undergo training in relevant test methods.
- Reviewing data associated with Special Request samples is also among the tasks assigned to the QCDA.
Minimum Requirements: The QCDA should possess a minimum of 1 to 3 years of experience working in a cGMP environment. Effective interpersonal skills, self-motivation, and the ability to interact with diverse personnel at all levels are essential. The ability to communicate effectively with other departments within the organization and function harmoniously in a team environment is also crucial. Preferred qualifications include knowledge of data integrity violations in the Quality Control Laboratory.
Education and Experience: The ideal candidate should hold a Bachelor's degree (B.S. or B.A.) in a science-related field such as Chemistry, Biochemistry, or Biology.