Senior Quality Associate

This is a fully remote position, open to applicants in Kentucky, +12 more states.

📋 Description

• Assist in the implementation, maintenance, and enhancement of the Quality Management System.

• Aid in the management of Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Labs (CTL).

• Create and review Standard Operating Procedures (SOPs).

• Deliver Quality Onboarding training.

• Facilitate vendor management activities.

• Review and authorize vendor documentation.

• Evaluate executed manufacturing records to support product disposition.

• Contribute to computer system validation efforts.

• Promote quality performance and continuous improvement initiatives.

• Assist in gathering metrics for the Quality Management Review.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree in Biology, Chemistry, or another relevant scientific discipline is preferred.

• Over 4 years of full-time cGMP Quality Assurance experience.

• Willingness to travel up to 35%.

• Familiarity with eQMS (e.g., ACE, TrackWise).

• Solid understanding of current industry practices and standards within an FDA-regulated biotechnology environment.

• Exceptional record-keeping and documentation capabilities.

• Strong verbal and written communication skills, with the ability to clearly present information in cross-functional scenarios.

• Experience with CDMOs is preferred.

• Proficient in using MS Office products.

• Ability to swiftly adjust to a dynamic environment and circumstances that require flexibility, tolerance, and a strong sense of urgency, while ensuring compliance with all cGMP and regulatory standards.

• Capable of working effectively both independently and as part of a team.

🏝️ Benefits

• Comprehensive health insurance for employees and their families.

• 401(k) matching contributions.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Generous Paid Time Off (PTO).

• Paid parking amenities.

• Subsidized commuter passes.

• Catered lunches in the office.

• Team-building events.

• Opportunities for community projects.

• Competitive compensation packages.