Quality Assurance Associate

Role Summary

The Quality Assurance Associate role provides daily assistance and guidance on 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. Location: Winslow, Maine.

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: Familiarity with applicable Global Regulatory, Quality and ISO standards such as FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), and CFIA (Canadian Food Inspection Agency).
• Required: Proven quality assurance experience in a regulated environment.
• 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 (Science or Engineering related degree) with 3+ years of relevant experience.
• M.S degree is highly preferred.

Additional Requirements

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