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Quality Assurance Associate

  • Permanent
  • Anywhere

Website Actalent

Actalent

Company : Actalent

Country: United States

Location : Exton, Pennsylvania

Post: Sat, 11 Sep 2021 05:09:38 GMT

Expires: Mon, 11 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

DESCRIPTION

* The Quality Assurance Associate interacts with each group to ensure accurate and compliant release of intermediates and final product. This will include:
* Review of Manufacturing Batch Record documentation for accuracy, completeness, and compliance with effective SOPs to ensure the strength, identity, safety, purity, and quality of the product
* Review and disposition of manufactured Bulk Drug Substance and Drug Product Injection lots
* Review of Quality Control testing data against established specifications
* Quarantine and Final Disposition of raw materials to Manufacturing and Quality Control
* Receipt of Quarantine Bulk Drug Substance vials for storage and distribution of Bulk Drug Substance vials for testing and/or manufacture
* Packaging of Biopsy Kits for shipment
* Packaging of final product for shipment
* Assist the Quality Assurance Management in daily operations, as needed
* Conducting Quality on the Floor audits within the Aseptic Processing Area (APA)
* Establish and monitor Quality Assurance programs and procedures to ensure compliance
* Write and revise Quality Systems SOPs as necessary to maintain compliance
* Training of other employees
* Conducting investigations through the use of problem-solving tools

QUALIFICATIONS

* Bachelor’s Degree in a Life Science (Biology, Biochemistry, etc.)
* 1+ years of hands on QA experience within a biologics or pharmaceutical company (laboratory experience will be considered as well)
* Batch record review and GMP experience a MUST

HOURS

* Monday through Friday; 1st shift

ABOUT ACTALENT: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

To apply for this job please visit www.resume-library.com.