- The QCDR should understand common data integrity violations in the Quality Control Laboratory. This knowledge is critical for the QCDR to be successful in this role.
- The QCDR will stay current on publications released by USP, EU, FDA and other pertinent organizations including publications associated with ISO 17025:2017 accreditation to ensure the Quality Control Department complies in the areas of analytical applications, release specifications, and documentation practices.
- The QCDR will review Quality Control Department in-house generated data reports, Contract Laboratory reports and Quality Control Certificates of Analysts using electronic signature in a timely manner. This may also include data packets associated with Method Validation or Method Development and review Certificates of Analysis produced after data review.
- The QCDR will assist with the review and write-up of Out-of-Specification and Out-of-Trend investigations generated in the QC laboratory, this includes Contract Laboratory investigations. The QCDR will ensure the responsible personnel/contract lab initiate investigations in a timely manner and ensure the review of data is performed in a timely manner for all stages of the investigation.
- The QCDR will assist with the initiation of investigation discussions with laboratory personnel and be involved with all diagnostic discussions occurring before investigation re-testing begins.
- Will receive training on test methods pertinent and prior to reviewing data reports.
- The QCDR will review data associated with Special Request samples.
Minimum Requirements: The QCDR should have 1 – 3 years working in a cGMP environment. Effective interpersonal, self-motivation skills, and the ability to interact with all levels of personnel are required. Communicate effectively with other departments within the organization and function within a team environment. Knowledge of data integrity violations in the Quality Control Laboratory is preferred.
Education and Experience: A Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in a science-related field such as Chemistry, Biochemistry or Biology.
