Quality Assurance Associate - California
Assist the Quality Assurance Manager by aiding with the implementation of the company’s quality assurance systems for the completion of testing services in accordance with client specifications, the company’s standard operating procedures, and regulatory agencies regulations.
- Reviews all laboratory raw data, including laboratory notebooks, printouts, logbooks, executed forms, to ensure data accuracy and integrity in accordance with cGMPs and company SOPs.
- Reviews all Test Reports to ensure results and reporting follows all regulatory and company standards.
- Ensures that Standard Operating Procedures are being followed. Assist with issuance, review, revisions, and archiving of SOPs and all quality documents.
- Act as site lead for Quality Event Reporting such as CAPA, OOS, Deviation and MOCs.
- Maintains up-to-date site Calibration, Qualification and PM instrumentation records
- Assist with performing internal audits, hosting client audits and conducting sub-contractor audits.
- Assist in maintaining the company’s training program assuring that all personnel receive adequate training to perform their job functions in accordance to cGMP’s and ISO guidelines
- Words on multiple projects in a concurrent manner on a routine basis.
- Assist QAM with additional tasks as needed.
A college degree is required with a major in science preferred or relevant work experience preferably in a contract testing laboratory subject to cGMP’s.
This is an entry to mid-level position, requiring at least three (3) years experience.
Good grammar and written/oral communication skills are required.
Must be detailed oriented and prior Quality Assurance experience is essential.