QA Coordinator

SUMMARY:

- Responsible for activities which are related to laboratory and documentation management which includes but is not limited to sample receipt, tracking and disposal, testing, retain samples, laboratory notebook issuance and archival in procedures aligned with US FDA, cGMP, Corporate Policies, Quality Standards (QS) and other applicable international GMP regulations and guidelines.
- The position is responsible for the efficient and accurate laboratory workflow and overall organization.

MAJOR RESPONSIBILITIES:

- Responsible for sample distribution to various testing sites
- Assemble and ship samples to various testing locations
- Complete all necessary documentation pertaining to sample shipment
- Receive and assemble all test results into product/material folders
- Supervises Retention Sample Program in accordance with cGMP regulations and procedures.
- Assure that all required product/material retains are stored in approved retain storage area(s).
- Organize, with the assistance of the Document Control Leader, all offsite document archival.
- Responsible for Laboratory Notebook Issuance and Archival
- QA/QC supply inventory management
- Must have excellent attendance

SKILLS:

EDUCATION:

- High School Diploma or equivalent
- AA Degree in Chemistry preferred

EXPERIENCE:

- A minimum of one year experience in a pharmaceutical industry environment with similar responsibilities.
- Strong analytical, organizational, and interpersonal skills are required.
- MS Word