Quality Assurance Analyst

4 weeks ago

rochester, United States Meet Full time

My client is seeking a dynamic and hands-on Quality Assurance Analyst to lead and manage our QA activities. As a key member of our small, agile team, you will be responsible for ensuring the highest quality standards are met.


Key Responsibilities:

  • Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety
  • Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
  • Strong purposeful presence on the manufacturing floor
  • Participates in and provides quality oversight for quality records including Deviations and Change Controls, assuring adherence to procedural requirements and regulatory expectations.
  • Reviews and approves controlled documents, including Standard Operating Procedures, Protocols and Reports.
  • Ensures 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.


Experience::

  • Bachelors Degree in Biochemistry, Biology, Chemistry, or 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 Join my client?

  • Be part of a pioneering biotech company dedicated to developing cutting-edge therapies.
  • Work in a collaborative and fast-paced environment with the opportunity to make a significant impact on the company’s success.
  • Competitive compensation package, including benefits and opportunities for professional growth.

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