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Quality Assurance Specialist

Employer
Waisman Biomanufacturing
Location
Madison, Wisconsin
Start date
Aug 26, 2019

The Quality Assurance (QA) Specialist will be responsible for QA documentation and record keeping, auditing, QA raw material control, quality systems (documentation control, failure investigation, deviation reporting, etc.) and training documentation. A Bachelor's degree is required. A degree in Biochemistry, Chemistry, Biology, Bacteriology, Virology or a related field is preferred.

Well-qualified applicants will have the following preferred work experience: 
- One to two years of experience performing Quality Assurance (QA) duties. Prior QA work experience in a manufacturing environment under current Good Manufacturing Practices (cGMP) is highly preferred. 
- Experience in documentation control including documentation initiation, review and approval as well as review and approval of manufacturing batch records.
- Experience reviewing documentation, performing inspections, completing QA documentation and releasing GMP raw materials. 
- Experience performing audits of vendors and contract laboratories by mail. 
- Experience providing support during audits by regulatory agencies and prospective clients (e.g., interacting with auditor(s), responding to resulting observations, providing documentation, etc.)

Unless confidentiality is requested in writing, information regarding applicants must be released upon request.  Finalists cannot be guaranteed confidentiality.  UW-Madison is an equal opportunity/affirmative action employer.

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