QA Specialist II

  • Permanent
  • Anywhere

Website Actalent


Company : Actalent

Country: United States

Location : Louisville, Colorado

Post: Sun, 19 Sep 2021 05:04:44 GMT

Expires: Tue, 19 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Actalent is actively hiring for a QA Specialist II for a nutraceutical company in Louisville, CO. This role is responsible for activities involving quality assurance and compliance with applicable FDA cGMP requirements. The person will provide oversight of Manufacturing QA operations with hands-on participation as needed, as well as management of various Quality Systems. Person will help coordinate the Quality stability program activities applicable to new and existing products.CORE RESPONSIBILITIES INCLUDE:Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Manufacturing QA:

* Responsible for overseeing Production Line clearance – providing back-up when needed
* Provide oversight of on-time Batch Release and back-up support as required, batch record review
* Review and approval of Document Change Requests as needed
* Oversee accuracy of part number assignment
* Support for resolution of complex Deviation Reports
* System design and support of Retention sample program, oversight of on-time Finished Product testing with back-up support as required


* Bachelors of Science or Associate degree and professional experience
* 2-5 years of experience in a comparable field
* 2-5 years of cGMP experience
* MS Office Suite – intermediate skill level

Please apply with an updated resume to 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.

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