QC Associate I

About the job

Duties

Coordinates day-to-day operations within lab to ensure products are analyzed within the accepted time frames. Ensure all HPLC and Client testing are tested to comply with the general laboratory, company policies, and current regulations and do not place patients at risk due to inadequate safety, quality or efficacy.

Ensures lot release and stability timelines will be met.

Interprets data and resolves technical issues.

Actively participate during group meetings and share information, as appropriate, with manager and peer. Effectively communicate with manager/all team members.

Assists trouble-shooting and implement corrective actions related to quality investigations.

Provides accurate and timely delivery of data and reports to support regulatory filings.

Creates and revises SOPs, methods, and/or test records for testing.

Participates in continuous improvement projects. Maintains specific QC files and database records for process and/or quality improvement efforts.

Skills

1-3 years of GMP experience Must be willing to work all shifts including weekend support but primary work hours are during the day