Quality Engineering - QA Specialists

Industry

Engineering

Advert ID

FOX_BBBH40373

Location

Durham

Job Type

Contract

Hours

Full-Time

Salary Range

Up to USD0.00 per year

No. of Openings

1

Branch Information

Raleigh Engineering - (USA) 701 Corporate Center Drive Suite 375 NC Raleigh , NC 27607

ContactNumber

919-755-5804

Job Description

JOB SUMMARY:

Provide on-the-floor compliance support as a Quality Assurance representative during critical manufacturing operations. Review of executed batch records and logbooks. Conduct QA walkthroughs, room clearance activities (including changeover), and participate in safety walkthroughs. Assist the Manufacturing Operations staff with assessment, initiation, notification, and closure of deviations from established procedures.



* Shift Schedule: Wednesday - Saturday / 9:00 pm - 8:00 am



JOB RESPONSIBILITIES:



* Performs on-the-floor inspections as a QA representative. Provides compliance support to manufacturing operators during critical manufacturing operations (at minimum). Works with the manufacturing group to resolve compliance issues.

* Performs QA review of executed batch records and logbooks.

* Works directly with Manufacturing Operations to resolve deviations and other compliance issues in a timely manner.

* Supports Release inspections (or changeover activities) at campaign start-up, including QA oversight of GMP readiness activities in Manufacturing.

* Participates in QA and safety walkthroughs of the cGMP manufacturing facility.

* Support Document Control for issuance of batch records as needed during off hours.

* Participates in process improvements

* Attend relevant meetings in support of manufacturing operations



MINIMUM REQUIREMENTS:



* BS and 8+ year experience or MS and 5+ years' experience in a Quality Engineering or Quality Assurance role or Equivalent.

* Technical knowledge of upstream and/or downstream processing techniques and equipment.

* Experience working at a cGMP manufacturing environment is required, with strong understanding of FDA, EU, and ROW cGMP regulations.