Understand common data integrity violations in the Quality Control Laboratory. This knowledge is critical to be successful in this role.

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.

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.

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.

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.

Review data associated with Special Request samples.

Must 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.

J-18808-Ljbffr

Last updated : 2024-04-26