Quality Assurance Associate

Role Summary

The Quality Assurance Associate provides daily assistance and guidance to issues such as non-conformance investigations, change controls, procedure/manufacturing batch record changes, validations, batch disposition, and qualification activities. The QA Associate works as a team member within the operations teams to achieve site goals while maintaining a strong quality mindset.

Responsibilities

• Ensure robust quality and compliance: Oversee and monitor quality systems, conduct thorough document reviews, and support regulatory inspections to maintain high standards.
• Facilitate batch disposition: Assist with the timely disposition of incoming, semi-finished, and finished materials, ensuring adherence to quality protocols.
• Lead and mentor on quality matters: Coach and guide operations and support personnel, fostering a strong understanding and application of quality principles.
• Drive deviation management and continuous improvement: Collaborate cross-functionally to investigate non-conformances, deviations, and CAPAs, leveraging Six Sigma tools and supporting Lean initiatives.
• Provide quality guidance for projects: Serve on project teams, offering expert input to ensure compliance and quality attributes are met throughout project lifecycles.

Qualifications

• Required: B.S. Degree or equivalent Microbiology/Biology/Chemistry/Engineering (Science or Engineering related degree preferred).
• Required: Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA, EU GMP, USDA, and CFIA.
• Required: Proven quality assurance experience in a regulated environment.
• Preferred: M.S degree is highly preferred.
• Preferred: Root cause analysis and troubleshooting skills.
• Preferred: Demonstrate strong oral, written, and interpersonal skills.
• Preferred: Strong ability to work on a team and lead without authority.
• Preferred: Technical writing skills.

Education

• B.S. Degree or equivalent Microbiology/Biology/Chemistry/Engineering (Science or Engineering related degree preferred).
• M.S. degree is highly preferred.

Skills

• Root cause analysis and troubleshooting
• Strong oral, written, and interpersonal communication
• Teamwork and leadership without direct authority
• Technical writing

Additional Requirements

• Location: Winslow, Maine
• Must not have contact with avian species (birds) at home due to the nature of the manufacturing.