Quality Assurance Associate – Change Control Coordinator

Quality Assurance Associate – Change Control Coordinator

Responsibilities:
- Coordinate and oversee daily activities in the site change management system
- Lead/support Change Review Board (CRB) activities and cross-functional collaboration
- Drive change controls to timely, compliant closure
- Communicate change status/timelines across departments
- Support deviation investigations (RCA and CAPA development)
- Provide technical review/guidance for quality documentation, investigations, and change controls
- Write, revise, and maintain QA procedures and controlled documents
- Support change-management quality metrics and trend identification
- Participate in audits, inspection readiness, and continuous improvement
- Independently manage QA projects with minimal oversight
- Support a strong quality culture through coaching and technical guidance

Qualifications:
- Bachelor’s degree in a scientific discipline (preferred)
- 8 years Quality Assurance experience in a regulated industry (FDA/USDA/ISO, etc.)
- Strong expertise in change control and root cause analysis; ability to independently manage cross-functional quality initiatives in a GMP environment

Preferred:
- 6+ years with change control systems and RCA tools (5 Whys, Ishikawa/6M)
- Experience approving GMP documentation/investigations/change controls
- Strong technical writing/communication; risk assessment and quality metrics reporting
- eQMS experience; Microsoft Office proficiency
- Organizational skills, cross-functional collaboration, coaching/mentorship

Benefits (highlights): Multiple relocation packages; 8-week parental leave; annual bonus; flexible work arrangements; up to 6% 401(k) matching.

Application instruction: If you don’t meet every requirement, you’re encouraged to apply.