QA Specialist II (Nights 12 hour Rotating Shift)
On-siteDurham, North Carolina, United States
Durham, North Carolina, United StatesOn-siteFull TimeLarge
Full TimeLarge
Job Summary
Execute batch record and logbook reviews, manage deviation triage, and conduct routine facility walkthroughs to ensure inspection readiness. Provide real-time GMP guidance on the cleanroom floor, support external client reviews, and respond to alarms. Review written procedures for accuracy and offer feedback as needed. Work on team initiatives, represent Quality in interdepartmental meetings, and track department metrics. Collaborate with Manufacturing to foster a compliant site environment. This role includes nights and 12-hour rotating shifts.
Required Qualifications
- GMP / regulated industry / laboratory experience
- Demonstrated ability to work in a team environment
- Demonstrated ability to understand the manufacturing process
- Ability to perform routine core MQA responsibilities
- Review written procedures for accuracy and provide feedback as needed
- Associate degree / Bachelor's degree
- appropriate years of experience
- Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization
- Demonstrated ability to represent Quality on interdepartmental meetings
- Demonstrated knowledge of technical documents
- Demonstrated ability to become qualified trainers
- Ability to track and trend department metrics
Desired Qualifications
- Degree progression
- Bachelor's degree
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