We are looking for a Quality Assurance Specialist III to join our QA team at our Rancho Cordova, California location!
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 Quality Professionals to join our team at our Rancho Cordova, CA location (Northern CA, greater Sacramento area).
Key Job Responsibilities:
Responsible for ensuring that adequate QA support is provided for the cross functional team meetings and Customer teleconferences
Communicates the status of QA related items to internal teams including batch release and investigation status
Takes an active role providing, as appropriate, guidance within the approved systems and procedures as it related to GMP production and release of products, some of this guidance may be required outside of the typical working schedule (off shift)
Responsible for taking an active role in planning and execution of action items related to support of production and product release, including document control and production record review activities.
Manages the release of products to support subsequent production and release of product to customer within the approved systems and procedures
Manages change controls in support of production and release activities
Reviews and/or conduct of investigations for deviations in production and testing (VAR, MNCRs, OOS/OOT investigations, QCRs)
Ensures process validation and qualification requirements are established in approved protocols and results of the validation and qualifications are adequately presented in approved reports.
Responsible for facility audits of the respective manufacturing facilities at the start of each campaign and periodically while long running campaigns are active.
The Quality Systems are managed within Master Control, an electronic document management system. These systems require coordinators to ensure timely progressions and accurate completion of documents. Examples of quality systems include (but are not limited to) Change Control, CAPA, Variances, MNCRs, Supplier Management and Customer Complaints. The Quality Assurance Specialist is expected to either support multiple programs or support the coordination of the quality systems, but not necessarily both.
This position may be filled at a higher or lower level, based upon the candidates experience per the Company's Job Families.
AMPAC Fine Chemicals offers competitive salaries and benefits, 401k and relocation assistance.
Strong written strong written and verbal skills, knowledge of cGMP, technical lead experience desired and verbal skills, knowledge of cGMP, technical lead experience desired. API and/or chemical manufacturing experience required. Pharmaceutical experience required.
4 openings. Employer will assist with relocation costs.
Additional Salary Information: Incentive bonus
About AMPAC Fine Chemicals
AMPAC Fine Chemicals is a leading manufacturer of active pharmaceutical ingredients and registered intermediates under cGMP guidelines for commercial customers in the pharmaceutical industry.