Quality Assurance Specialist I

AMPAC Fine Chemicals•Rancho Cordova, CA

5d•Onsite

About The Position

SKpharmteco 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 enthusiastic Quality Professionals to join our Quality Assurance Team! We have opportunities at our Rancho Cordova, CA (greater Sacramento area). Quality Assurance Specialist I is responsible for supporting multiple programs or supporting the coordination of the quality systems, but not necessarily both. The Quality Assurance Specialist I will be responsible for ensuring that adequate QA support is provided for the cross functional IPT meetings and customer teleconferences. Work is closely supervised.

Requirements

Associates degree required.
0-2 years of related technical experience or equivalent combination of education and experience.
Strong attention to detail.
Ability to work in a fast paced, team-oriented environment.
Ability to act with a sense of urgency, while maintaining accuracy and data integrity.

Nice To Haves

Bachelor’s degree preferred in an appropriate science.

Responsibilities

Communicating the status of QA related items to the IPT Team including batch release and investigation status.
Providing 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).
Planning and execution of action items related to support of production and product release, including document control and production record review activities.
Managing the release of products to support subsequent production and release of product to customer within the approved systems and procedures.
Managing change controls in support of production and release activities.
Review and/or conduct of investigations for deviations in production and testing (VAR, MNCRs, OOS/OOT investigations, QCRs).
Ensuring process validation and qualification requirements are established in approved protocols and results of the validation and qualifications are adequately presented in approved reports.
Facility audits of the respective manufacturing facilities at the start of each campaign and periodically while long running campaigns are active.
Ensuring that reports within a given system are progressing in a manner that complies with the approved procedures and deadlines.
Ensuring submitted reports contain adequate information and attachments/links to allow appropriate review and approval.
Assignment and/or reassignment of appropriate personnel to the documentation, review and approval of quality systems reports.
Development and reporting of appropriate metrics for review by management and to obtain and maintain appropriate training for the requirements of this role.