Quality Assurance Specialist

Company: AMPAC Fine Chemicals
Location: Rancho Cordova
Posted on: November 22, 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 Quality Assurance Specialists to join our QA team at our Rancho Cordova (Greater Sacramento, CA) location! WE WILL PAY TO RELOCATE YOU!

Key Job Responsibilities:
Responsible for ensuring that adequate QA support is provided for the cross functional IPT meetings and Customer teleconferences
Communicates the status of QA related items to the IPT Team 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 active support for GMP production of product is managed by an Integrated Product Team (IPT). The core team will include a representative from the Quality Assurance organization (IPT QA lead ) as the primary point of contact for a given product/program. 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.

Requirements:
Bachelors degree in an appropriate science and 5 years of related technical experience or equivalent combination of education and experience.

Skills:
Strong written and verbal skills, knowledge of cGMP, API Manufacturing, CMO, knowledge of pharmaceutical manufacturing, and technical lead experience desired

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.

AMPAC is an Equal Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender expression or identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics, both state and federal.

At AMPAC Fine Chemicals, the health and safety of our employees is our number one priority. Offers of employment are contingent on the candidate showing proof of being fully vaccinated against Covid 19 (currently one dose of the Johnson & Johnson vaccine or two doses of the Pfizer or Moderna vaccine) to pass the pre-employment requirements.

Keywords: AMPAC Fine Chemicals, Rancho Cordova , Quality Assurance Specialist, Other , Rancho Cordova, California