Quality Assurance Lead

1 week ago


Rochester, Minnesota, United States Meet Full time
Quality Assurance Analyst

Meet our client, a pioneering biotech company dedicated to developing cutting-edge therapies. We are seeking a dynamic and hands-on Quality Assurance Analyst to lead and manage our QA activities.

Key Responsibilities:
  • Partner with our colleagues in Manufacturing, Supply Chain, Facilities, and Engineering to maintain our strong culture of Quality and Safety.
  • Provide Quality Oversight of the manufacturing facility, including manufacturing operations, testing, inspection, and utilities.
  • Participate in and provide quality oversight for quality records, including Deviations and Change Controls, ensuring adherence to procedural requirements and regulatory expectations.
  • Review and approve controlled documents, including Standard Operating Procedures, Protocols, and Reports.
  • Ensure that operations align with applicable regulations, Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
  • Contribute to and drive continuous improvement projects in cross-functional collaboration.
Requirements:
  • Bachelor's Degree in Biochemistry, Biology, Chemistry, or a related science field.
  • Demonstrated ability to perform GMP operations, including following detailed SOPs, maintaining training, and good documentation practices.
  • Experience managing projects through to completion, meeting timelines.
  • Ability to evaluate documentation and operations according to company procedures.
  • Experience working with Quality Systems.
  • Strong organizational skills and ability to manage multiple tasks at one time.
  • Effective communication skills (both written and verbal).
  • Demonstrated ability to work as both a team player and independently.
  • Display leadership attributes and drive improvement initiatives.
  • Solid understanding and application of aseptic behaviors and principles.

Why work with us? We offer a competitive compensation package, including benefits and opportunities for professional growth, in a collaborative and fast-paced environment with the opportunity to make a significant impact on our company's success.



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