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Specialist, QA Operations
90 Digital Drive Novato, CA 94949 US
Job Description
Target PR Range: 19-25/hr
*Depending on experience
Duties:
This position reports to the Quality Assurance Supervisor/ Manager/ Senior Manager and is responsible for quality oversight of one or more processes relating to make, assess, and release for products produced in Novato manufacturing facilities.
The responsibilities in the role include the following:
Provide quality oversight of one or more portions of operations including, but not limited to;
Direct observation of manufacturing operation for adherence to GMP.
Review of GMP documentation from manufacturing and/ or QC, which can include log books, batch records and test records.
Issuance of Production Batch Record to Manufacturing
Scanning and archiving executed production batch records
Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations a plus (additional jurisdictions a plus).
Revise QA related procedures as needed.
Skills:
Attention to detail. MS Office. Ability to operate basic office equipment, e.g. scanners, printers.
Education:
Associate degree or higher.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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