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Quality Assurance Specialist

Minnetonka, MN 55343

Posted: 09/13/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 583742 Is job remote?: No Country: United States

Job Description

How you will make an impact

The Quality Assurance Contractor performs a wide range of Quality Assurance functions related to programs. They provide QA support of CMOs, review and processing of change controls, review of product related investigations, deviations, technical protocols and reports including analytical method validations and method transfers, reference standards protocols and reports. Pay rate range: $40-48/hr

In this role, you will have the opportunity to:

•    Support our Contract Manufacturing Organizations (CMO)
•    Master Batch Record reviews and approvals
•    Executed Batch Record reviews and deviation resolution
•    Ensure GMP compliance profile is maintained
•    Ensure products meet all release tests
•    Ensure products meet established expiry dating
•    Perform assessments of raw material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements

To succeed in this role, you will need:

•    A minimum of Bachelor’s degree with at least 6 years’ experience in the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered)
•    Experience in the manufacturing of GMP products
•    Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents

In return, we offer you:

•    Remote/hybrid position
•    A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.
 
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