Quality Assurance Specialist
Company: AMPAC Fine Chemicals
Location: Rancho Cordova
Posted on: November 22, 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 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
Manages the release of products to support subsequent production
and release of product to customer within the approved systems and
Manages change controls in support of production and release
Reviews and/or conduct of investigations for deviations in
production and testing (VAR, MNCRs, OOS/OOT investigations,
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.
Bachelors degree in an appropriate science and 5 years of related
technical experience or equivalent combination of education and
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
Keywords: AMPAC Fine Chemicals, Rancho Cordova , Quality Assurance Specialist, Other , Rancho Cordova, California
Didn't find what you're looking for? Search again!