QA Compliance Specialist at Lonza
Lee, NH
About the Job
United States, Portsmouth (New Hampshire)
Posted Job Advert
Summary
A Principal Operations Specialist I through their fundamental knowledge,
assists GMP associates by providing first level, real-time Quality Assurance
support for operational areas directly or indirectly involved in the execution of
GMP-related activities. At the first principal level, Primary responsibilities
include batch record review (paper and electronic), logbook review, analytical
testing review, Quality Tag Outs, release of areas and equipment from product
changeover and other GMP records as applicable, as well as coaching &
mentoring the associates with GMP tasks. QA Principal Operations Specialist I act as the eyes and ears of Quality Assurance within operational areas, helping to ensure that the facility is inspection-ready and GMP operations and documentation are in compliance.
Responsibilities
Qualifications
Reference: R62911
Posted Job Advert
Summary
A Principal Operations Specialist I through their fundamental knowledge,
assists GMP associates by providing first level, real-time Quality Assurance
support for operational areas directly or indirectly involved in the execution of
GMP-related activities. At the first principal level, Primary responsibilities
include batch record review (paper and electronic), logbook review, analytical
testing review, Quality Tag Outs, release of areas and equipment from product
changeover and other GMP records as applicable, as well as coaching &
mentoring the associates with GMP tasks. QA Principal Operations Specialist I act as the eyes and ears of Quality Assurance within operational areas, helping to ensure that the facility is inspection-ready and GMP operations and documentation are in compliance.
Responsibilities
- Perform the daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits.
- Provide some coaching and feedback for GMP and documentation behaviors, working with Manufacturing Management
- Provide GMP guidance to Manufacturing for routine and non-routine issues. Elevate more complex issues to senior staff and Management. •
- Respond to QA Hotline calls in support of GMP operations. QA Principal Operations Specialist I is able to make most simple GMP decisions independently. With complex decision making, they are working with senior staff or management.
- Learn from guidance and compliant decision making of senior staff and management
- Document all items within QAOTF shift notes, provide follow-up for other shifts as needed.
- Authorize placement and removal of Quality Tag Outs, release equipment from Product Changeover.
- Represent QA in meetings or on project teams, learning decision making as a QA representative conferring with senior staff.
- Perform other duties as assigned.
Qualifications
- High School Diploma required
- Bachelor's Degree preferred
Reference: R62911
