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Quality Associate II

Durham, NC 27709

Posted: 07/15/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 610752 Is job remote?: No Country: United States

Job Description

The primary responsibilities of the QA Associate II include, but are not limited to, the timely and accurate issuance of GMP documents and records (BPRs, SLRs, Labels, and Logbooks) required to support internal site production operations. In addition, they will perform review of executed GMP documents (Standard Operating Procedures, Master Production Records, Solution Records, Labels, and Logbooks) for compliance to applicable regulatory and corporate guidance documents and identify and assess discrepancies with business source documentation.

The QA Associate II will also support the generation of Quality Systems performance metrics and report these metrics when required.

Accountability Description
1. Issuance of Batch Production Records, Solution Lot Records, Labels, and Logbooks
2. Review of Batch Production Records, Solution Lot Records, Labels, and Logbooks
3. Review and approve site-specific GMP documents and records. This includes, but is not limited to, document creation, revision, review, change control guidance/review/approval, document issuance oversight, and document maintenance
6. Prepare for and support site inspections and audits.

The position requires but is not limited to the following:
•Strong oral and written communication skills; ability to communicate with management and peers effectively
•Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel
•Demonstrated troubleshooting and problem-solving skills
•Knowledge of FDA/EMEA regulations and compliance.

Incumbent should have a Bachelor of Arts/Science Degree (BA/BS) in Life Science or other technical discipline preferred with 2-3 years related experience. Approximately, 2-3 years’ experience in pharmaceutical or biotech manufacturing environment is recommended.

Pay ranges between $26-36/hr based on experience 
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About Durham, NC

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