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Quality Assurance Specialist

  • LocationRochester, MN 55901 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:3 days ago
  • Job no: 39570
  • Category: Quality

Job Description


A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Quality Assurance Specialist role. Our client, a leading biotechnology company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. Responsibilities include:


1) Develop and oversee the product manufacturing compliance program

2) Monitor operations in the production rooms

3) Provide direct QA support during manufacturing operations

4) ork with manufacturing staff to ensure the compliance with regulatory requirements associated with internal and external assessments and responses to citations

5) Develop regulatory and compliance training program for the intended audience

6) Maintain program and keep it up-to-date

7) Perform review of product manufacturing documents for clarity and compliance with regulatory requirements

8) Ensure the compliance concerns are prioritized and resources identified

9) Ensure that product manufacturing service risks are escalated to management

10) Develop CMC expertise related to company manufacturing and ensure the change management activities are in place to support reporting requirements for regulatory filings

11) Coordinate CMC reviews and submissions for GMP manufacturing

12) Maintain CMC files

13) Lead the investigation of events that appear to be associated with regulatory violations

14) Work with relevant parties to resolve issues and take appropriate corrective and preventive action


Critical Requirements



1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biotechnology industry is strongly preferred

4) Preference will be given to candidates with recent experience in quality assurance


If you are qualified and this seems like just the right opportunity to take your career to the next level, please apply – we want to hear from you!


Compensation and Other Details


Base Salary: Highly competitive package, commensurate with experience

  • Published on 24 Nov 2021, 12:55 PM