Specialist, Quality Systems & Compliance

Specialist, Quality Systems & Compliance Skip to main content
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Not Applicable locations:
USA
- North Carolina
- Durham (Old Oxford) time type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
July 4, 2026 (7 days left to apply) job requisition :
R404840
** Job Description
**** Must be able to work 12 hour night shift 6:00 pm to 6:00 am; 2-2-3 schedule.
** Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Assurance Associate Specialist provides Quality support to both laboratory and manufacturing operations. The successful candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operation of vaccine product manufacturing facilities. The successful candidate must be able to examine issues from various perspectives, provide a hands-on approach to problem solving, and be self-motivated to identify and initiate process improvement projects.

The Quality Assurance Specialist provides support to vaccine, biologic, and sterile manufacturing processes through collaboration with Technical Operations.
** Primary activities could include:
*** Perform review of batch records, laboratory records and associated documentation.
* Provide quality guidance and assistance in deviation identification and initiation.
* Perform data review and run reconciliation activities as required (i.e., UV and FIT testing).
* Learn new processes and procedures.
* Perform shift work as required.
* Support housekeeping and self-inspections.
* Perform Quality retain sample management activities, if applicable.
** Education

Minimum Requirements
** High School Diploma or equivalent.
** Required Experience and Skills
*** Minimum two (2) years’ experience in Manufacturing, Maintenance, Military environments, or relative industry experience.
* ** Must be able to work 12 hour night shift 6:00 pm to 6:00 am; 2-2-3 schedule.
**** Preferred Experience and Skills
** Good interpersonal skills including flexibility and collaboration. Demonstrated analytical aptitude, critical thinking skills, and problem solving. Good verbal and written communication skills.#MSJR
*
* Required Skills:

** Analytical Problem Solving, Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Communication, Complaint Management, Decision Making, Deviation Management, Global Manufacturing, Good Manufacturing Practices (GMP), Manufacturing, Oral Communications, Performance Improvement Plans, Problem Solving, Process Improvement Projects, Process Improvements, Quality Assurance (QA), Quality Auditing, Quality Management, Quality Management Standards, Quality Management Systems (QMS), Quality Standards, Quality Support, Root Cause Analysis (RCA), Sterile Procedures {+ 1 more}
** Preferred

Skills:

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