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QA Associate

Company: Apex Systems
Location: Petaluma
Posted on: June 7, 2020

Job Description:

Areas of Responsibility bull Review of batch production records for completeness and release bull Review of analytical records and any supporting documentation to ensure compliance with cGMPs bull Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations. bull Perform routine document control activities including creation andor revision, processing, routing and review. bull Work with various departments to set up appropriate documentation to improve efficiency and accuracy. bull Assists in performing QC data review for batch record in-process and final QC approval. bull Assist with internal Quality audits of internal departments, as necessary. bull Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance. bull May be called upon to assist with the Supplier Qualification program. bull Provide guidance and train others on Quality System and Quality Assurance procedures. EducationExperience bull AA, AS in Chemistry, Biochemistry, Biological Sciences or a similar scientific discipline or equivalent combination of education and experience. bull 2-3 years' experience in a diagnostics or medical device environment preferred Quality Assurance experience preferred. EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservicesapexsystemsinc.com or 844-463-6178.

Keywords: Apex Systems, Petaluma , QA Associate, Other , Petaluma, California

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