Quality Assurance Associate

Role Summary

Quality Assurance Associate

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.

Skills

• Root cause analysis and troubleshooting skills.
• Strong oral, written, and interpersonal skills.
• Ability to work on a team and lead without authority.
• Technical writing skills.

Education

• MS degree is highly preferred.

Additional Requirements

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