Document reviewer

Kelly Science and Clinical has a great opportunity for a QC Document Reviewer opening with one of our growing clients focused on the well being of animals and humans.

This is a direct hire opportunity and also potential for bonuses annually.

Location : Lancaster SC

Shift : Second M-F 3 : 30-11 : 30pm

Salary Range : $50,000-$55,000

Roles and Responsibilities :

• The Quality Control Document Reviewer (QCDR) reports to Quality Control (QC) Management.
• 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 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.
• Perform other assigned duties as may be required in meeting company objectives

Minimum Requirements :

• The QCDR should have 0 - 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.

9197095

Last updated : 2024-03-29

Salary : $50,000 - $55,000