Quality Assurance Specialist II
Company: American Pacific Corporation
Location: Rancho Cordova
Posted on: June 3, 2021
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
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
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.
- 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
- Provide Lead QA support as a team member for one or more
programs / customers.
- Provide appropriate guidance to internal IPT, may be during
- Manage the release of process equipment, intermediate products,
and final product/API.
- Author/Review deviation investigations, change controls, and
- Ensure that processes are appropriately validated and
- Maintain appropriate training for the responsibilities of this
- Provide primary QA support for customer or program.
- Ensure adequate support is being provided for internal and
- Support for Regulatory and Customer audits.
- Responsible for facility audits.
- Author plant trial protocols and reports.
- Associates Degree required. Bachelor's degree preferred in an
- 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.
- Strong attention to detail.
- Ability to work in a face paced, team-oriented
- 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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