Quality Assurance Specialist - 1st Shift

We are seeking a high-caliber QMS Specialist to manage the lifecycle of quality events. The QA Specialist will be responsible for investigating customer complaints, processing deviations, and overseeing the change control system to ensure that all modifications to processes or products are handled without compromising quality or regulatory standing.

Requirements

• Bachelor's degree plus 2 years experience in a GMP environment
• Proficiency in root cause analysis tools such as the 5 Whys, Fishbone Diagrams, and FMEA
• Experience with QMS software/Electronic Document Management Systems (e.g., MasterControl, EtQ Reliance, or TrackWise)
• Strong interpersonal and communication skills to influence cross-functional teams without direct authority
• Proven ability to write clear, concise, and evidence-based investigation reports

Benefits

• Paid time off
• 401(K) retirement savings with company match
• Medical, dental and vision
• Pay annual targeted bonus
• Competitive pay
• Life insurance
• Flexible spending account
• Tuition reimbursement