Foster City, California,
* opens in a new window
One of the leading Biopharmaceutical companies from the peninsula is looking for QA II/III level candidates interested in temporarily joining their Quality Assurance department. This company is very reputable and well-known. Please take a look at the description below, and if you're interested, then please apply!DESCRIPTION:
* Participates in developing Standard Operating Procedures to ensure quality objectives are met.
* Facilitate, review, and approve major and minor investigations related to GxP operations.
* Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
* Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
* Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.
* Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.
* May assist with compliance audits as required.
* Facilitate cross-functional meetings with internal and external parties as required.
* Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
* Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required.
* Supports the maintenance and improvement to quality systems processes, as needed
* Participate in the development of training programs regarding all aspects of producing quality products, as required.
* Assist compliance audits and provide SME support as required for regulatory inspections.
* Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
SKILLS: CFR 21, Microsoft Word, document formating, document templates, EQMS, QA, Document Control., deviation ABOUT ACTALENT: 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. Were 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.
* opens in a new window