Quality Assurance Associate (Document Reviewer)

Elanco•Winslow, ME

7d•Onsite

About The Position

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.

Requirements

B.S. Degree or equivalent (Science or Engineering related degree preferred) with 3+ years of relevant experience.
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).
Proven quality assurance experience in a regulated environment.

Nice To Haves

M.S degree is highly preferred.
Root cause analysis and troubleshooting skills.
Demonstrate strong oral, written, and interpersonal skills.
Strong ability to work on a team and lead without authority.
Technical writing skills.

Responsibilities

Oversee and monitor quality systems, conduct thorough document reviews, and support regulatory inspections to maintain high standards.
Assist with the timely disposition of incoming, semi-finished, and finished materials, ensuring adherence to quality protocols.
Coach and guide operations and support personnel, fostering a strong understanding and application of quality principles.
Collaborate cross-functionally to investigate non-conformances, deviations, and CAPAs, leveraging Six Sigma tools and supporting Lean initiatives.
Serve on project teams, offering expert input to ensure compliance and quality attributes are met throughout project lifecycles.