Biotech Quality Assurance Specialist

2 weeks ago


Rochester, Minnesota, United States Vyriad Full time
Job Summary

We are seeking a highly skilled Biotech Quality Control Analyst to join our team at Vyriad. As a key member of our quality assurance team, you will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities
  • Perform and maintain test systems for GMP manufacturing, and responsible for performing assays related to in-production and post-production product quality.
  • Qualify and validate analytical methods to maintain analytic validity of test methods.
  • Monitor aseptic manufacturing suites for contamination and maintain equipment and instruments.
  • Monitor production processes for compliance with processes and procedures and participate in non-conformance and complaint investigations.
  • Support other manufacturing work areas including supply chain staff in raw material inspections and supplier management program.
  • Collate records for the final batch record review and determine creative approaches to solutions using advanced professional expertise.
Requirements
  • Bachelor's degree in a science-related field.
  • Minimum of 2 years' experience performing and validating assays and/or working in a manufacturing quality control role.
  • Compendial assay experience and microbiology and environmental monitoring experience.
  • Prior pharmaceutical or biotech experience is preferred.
Preferred Qualifications
  • Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing and testing.
  • Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
  • Exceptional human relations and communication skills.
Working Conditions

Prolonged periods of sitting at a desk and working on a computer.

Vyriad is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, genetic information, gender identity, sexual orientation, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local laws.



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