Quality Assurance Officer I- Temporary Position

SSI Diagnostica Group•Radford, VA

1d•$17 - $23

About The Position

The Quality Assurance Officer I ensures that TechLab products meet quality system requirements. Responsibilities include reviewing and tracking products and checking documentation for compliance with regulatory standards. The position is based at the Techlab site and is a five-month appointment through a staffing agency. It reports to the Quality Assurance Manager or QA Supervisor.

Requirements

High school diploma and 2 years of experience in a GMP/FDA environment, or an associate degree and 1 year of experience in a GMP/FDA environment, or a B.A. or B.S.
Must be able to lift upwards of 30 pounds.

Nice To Haves

Life science degree preferred but not required.

Responsibilities

Issue and review MBRs in support of the production schedule.
Issue or confirm lot expiration dates for raw materials, components, and finished products.
Create, review, and apply QA release labels.
Review QC results as detailed in SOPs, RMSs, and PRSs.
Ensure approved documents, including MBRs, SOPs, and TLFs, are issued and controlled.
Ensure controlled records are controlled and easily retrievable.
Initiate proposed changes as Document Circulation Requests and Sage Change Requests.
Perform visual inspection of raw materials, foil and labels, and AQL testing.
Ensure non-conformities and CAPA are identified, investigated, and controlled.
Initiate non-conformity documentation and determine quality impact.
Deliver new-hire training.
Approve lot expiration dates.
Disposition pre-raw and raw materials, components, and finished goods.
Approve manufacturing and packaging MBRs.
Complete projects as assigned by the QA Manager or QA Supervisor.