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Quality Assurance Specialist III

Company: AMPAC Fine Chemicals
Location: Petersburg
Posted on: April 9, 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 a Quality Assurance Specialist III to join our QA team at our Petersburg, Virginia location!
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: Bachelor's 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, 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. PI132337122

Keywords: AMPAC Fine Chemicals, Richmond , Quality Assurance Specialist III, Other , Petersburg, Virginia

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