Senior Quality Control Associate

  • Anywhere

Company :

Location :
Lexington, Massachusetts

Expiry Date :
Sat, 27 Mar 2021 23:59:59 GMT

Apply Job :
Open Link

Description :

* Execution of testing for incoming raw materials, intermediate bulks, finished goods, and stability monitoring samples following SOPs, Work Instructions (WIs), and GMP guidelines.
* Document and analyze data following approved work instructions while adhering to GMP guidelines.
* Assist with the maintenance of QA monitoring programs, such as internal audits.
* Support new process development and continuous improvement by integrating QC tools and techniques.
* Participate in lab investigations as required.
* Maintain QC inventory and tracking systems.
* Update and monitor data trending of reagents and QC tests.
* Creating or updating Work Instructions and SOPs as required.

Skills and Experience:

* B.S. in the Life Sciences: Biochemistry, Molecular Biology, Biotechnology, etc., with 3-5 years in an industry setting. In-vitro diagnostics environment is preferred.
* Understanding of molecular biology, assay development, and DNA diagnostic chemistry is highly desirable.
* Experience in laboratory techniques especially qPCR, PCR and UV/VIS.
* Experience using Arena Software desirable.
* High attention to detail adhering to regulatory guidelines.
* Success working in a team-based cross-functional organization.
* Must be highly self-motivated, and an excellent communicator with strong analytical skills.
* Demonstrated ability to work in a fast-paced environment and maintain focus on deliverables.