Description
Responsibilities include:* Provide auditing services for all DEA, cGCP, cGLP and cGMP departments
* Assist with new review of batch production records
* Assist, as needed, with QA raw material Quarantine and Release functions, including maintenance of reserve sample inventory as part of the auditing function
* Review QC final product and stability data
* Track/follow up on outstanding Deviations/Discrepancies
* Prepare final product Certificates of Analysis as needed
* Coordinate issuance of lot-numbered batch production records
* Inspect printed finished product vial labels and labeled clinical vials for accuracy, correctness and legibility
* Assist with performance/follow-up of internal department and/or controlled substance accountability audits
* Assist with performance/follow-up of external audits of component vendors and contract laboratories
* Assist with regulatory inspections as needed
Position requirements:
* BS degree in Chemistry (or equivalent experience) AND 4 years of relevant Quality Assurance experience
* Strong knowledge of cGMPs and their application
* Familiarity or prior experience with aseptic processing
* Must have prior experience with internal/external audit procedures for all regulatory agencies
* Proficiency with Microsoft Word and Excel applications, and Electronic Document Management Systems (EDMS)
* Ability to work proactively with managers to solve quality problems and observation issues
* Ability to manage multiple responsibilities with a high degree of self-motivation
* Ability to travel, as needed, which will include international locations
* Excellent written, oral and interpersonal communication skills
To find out more about Real Staffing please visit www.realstaffing.com