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Quality Assurance Specialist II

Company: American Pacific Corporation
Location: Rancho Cordova
Posted on: June 3, 2021

Job Description:

AMPAC Fine Chemicals (AFC), an SK pharmteco company, is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities located in California, Texas, and Virginia specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities.

We are looking for enthusiastic Quality Professionals to join our Quality Assurance Team! We have opportunities at our Rancho Cordova, CA (greater Sacramento area). We will pay for your relocation!

The Quality Assurance Specialist II is responsible for supporting multiple programs and / or supporting the coordination of the quality systems. The Quality Assurance Specialist II will be responsible for ensuring that adequate QA support is provided for the cross functional IPT meetings and customer teleconferences.

KEY RESPONSIBLITIES:

  • Provides technical solutions to a variety of technical problems of moderate scope and complexity.
  • Issuance of controlled documents to support Operations.
  • Review of production records to support material and equipment release.
  • Provide Lead QA support as a team member for one or more programs / customers.
  • Provide appropriate guidance to internal IPT, may be during off-shift hours.
  • Manage the release of process equipment, intermediate products, and final product/API.
  • Author/Review deviation investigations, change controls, and material non-conformances.
  • Ensure that processes are appropriately validated and documented.
  • Maintain appropriate training for the responsibilities of this position.
  • Provide primary QA support for customer or program.
  • Ensure adequate support is being provided for internal and external meetings.
  • Support for Regulatory and Customer audits.
  • Responsible for facility audits.
  • Author plant trial protocols and reports.

Education

  • Associates Degree required. Bachelor's degree preferred in an appropriate science.

Experience

  • 4 -7 years with an AA degree and related technical experience or equivalent combination of education and experience.
  • 2-5 years with a BS degree and related technical experience or equivalent combination of education and experience.

Skills

  • Strong attention to detail.
  • Ability to work in a face paced, team-oriented environment.
  • Ability to act with a sense of urgency, while maintaining accuracy and data integrity.

This position may be filled at a higher or lower level based on the Job Family.

AMPAC Fine Chemicals offers competitive salaries, benefits, 401k and relocation assistance.

Keywords: American Pacific Corporation, Rancho Cordova , Quality Assurance Specialist II, Other , Rancho Cordova, California

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