Senior Quality Assurance Associate

Role Summary

The Senior Quality Assurance Associate on the second shift (1:00 pm – 11:00 pm, Monday–Thursday) performs activities within the Quality Department, providing QA oversight and support to Manufacturing Operations, Quality Control, and other functions. This includes on-the-floor support, collaborating with the Manufacturing team to address concerns in real time, document review, and project support. The position requires a decisive, detail-oriented person with strong communication and organizational skills.

Responsibilities

• Provide Quality Assurance oversight and support for manufacturing and Quality Control during Swing Shift activities
• Create, revise, review and approve documentation in Quality Assurance operations, including batch records, deviations, OOS, CAPA, protocols, and change controls
• Lead investigations for quality exceptions, as assigned
• Data review as necessary
• Write, edit, review, approve, and implement Standard Operating Procedures (SOPs) and Quality Policies
• Perform internal systems and compliance audits
• Support regulatory inspections
• All other duties as assigned

Qualifications

• 5+ years of relevant work experience in a cGMP environment with progressive responsibilities
• GxP leadership experience preferred
• Experience in a variety of QA responsibilities preferred
• Requires thorough understanding of Quality System requirements in support of cGMP regulations
• Detail oriented with strong interpersonal, oral and written communication skills
• Ability to make sound quality decisions based on risk analysis and regulatory/procedural requirements
• Ability to organize time for multiple tasks in a dynamic environment
• Ability to work effectively under matrix organization with multiple deadlines
• Work proactively to lead the quality effort at the company

Education

• BS degree in life science or technical discipline