Actalent Remote Senior Quality Systems Specialist in San Francisco, California
A well-known and reputable Pharmaceutical company istargeting a fully remote candidate to join their team. This position will work 100% remotely supporting this client, their CMOs, and producing Pharmaceutical products. Typical hours will be 9-5 PST. A more detailed description of the role can be found below!
Perform batch record review of parenteral drug products, assemble the batch record and release the product for shipment
As part of these activities, identify deviations and exceptions to generate a problem report which address these issues; including navigating through the deviation to identify the root cause and solution the problem, if possible.
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
Reviews manufacturing, deviations, change controls, environmental monitoring and quality control data for in-process and finished products.
Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
Perform review of deviations and CAPA’s
Additional Skills & Qualifications:
5-7+ years of experience relevant to job description.
Performing review of deviations and CAPAs of pharma parenterals
Must be able to work independently with closing our related investigations and reviews
Ability to support PST hours (8-5pm, generally)
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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