Quality Assurance Associate II

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 skillsTo find out more about Real Staffing please visit www.realstaffing.com