Job Description
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).
Job Summary:
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.
Duties and Responsibilities:
Responsible for communicating the status of QA related items to the IPT Team including batch release and investigation status
Take 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.
Responsible for managing the release of products to support subsequent production and release of product to customer within the approved systems and procedures
Responsible for managing change controls in support of production and release activities
Responsible for review and/or conduct of investigations for deviations in production and testing (VAR, MNCRs, OOS/OOT investigations, QCRs)
Responsible for ensuring 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.
Responsible for ensuring that reports within a given system are progressing in a manner that complies with the approved procedures and deadlines
Responsible for ensuring submitted reports contain adequate information and attachments/links to allow appropriate review and approval
Responsible for assignment and/or reassignment of appropriate personnel to the documentation, review and approval of quality systems reports
Responsible for the development and reporting of appropriate metrics for review by management and to obtain and maintain appropriate training for the requirements of this role
EDUCATION AND EXPERIENCE
COMPETENCIES/SKILLS
CERTIFICATIONS and LICENSES
This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time
SKPT offers competitive salaries, benefits, and matching 401k. Our Company 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.
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