Lead Process Technician - QA Floor ; Night Shift
Job in
Durham, Durham County, North Carolina, 27703, USA
Listed on 2026-07-09
Listing for:
BioSpace
Full Time
position Listed on 2026-07-09
Job specializations:
-
Quality Assurance - QA/QC
Production QC/QA, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
The Lead QA Floor Lead Tech is responsible for providing daily support and oversight to GMP operations in Raleigh‑Durham, North Carolina. The Lead QA Floor Support Lead Tech works as a team member supporting multiple production functions (formulation, filling, visual inspection) from operations to maintenance to achieve site goals while providing quality oversight and guidance.
Job Responsibilities- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
- Provides daily presence in operational areas to:
- Monitor GMP programs and quality systems and ensure adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel
- Monitor for, retrieve, and complete review of all paperwork needing quality review in each area supported and coordinate delivery to the associated area when complete
- Support visual‑inspection AQL inspection
- Review and approve GMP documentation in support of daily operations such as:
- Cycle Summary Reports for equipment
- Electronic batch record initiation
- Daily documentation of quality on the floor oversight
- Maintenance action plans
- Return to Service and Release of equipment, product, and area holds
- Work Order assessments and issue resolution
- Other documents as required
- Provide guidance and assistance in identifying potential product quality impact and assessing if observations are required
- Perform observational requirements for Aseptic Process Simulation 14‑Day Reads and supporting observation during formulation and fill‑related aseptic activities
- Provide QA systems support to reconcile issues in multiple systems such as:
- SAP (inventory management)
- PMX (electronic batch record)
- Track Wise (compliance)
- Veeva (controlled document repository)
- GMARS (calibration and maintenance system)
- And other systems as required
- Work within the team to ensure all manufacturing areas receive QA support needed to maintain daily operations
- Review GMP documents (e.g., procedures, protocols, and production record instructions)
- High School / GED minimum
- Demonstrated relevant pharmaceutical experience in aseptic manufacturing
- Associate’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred
- Strong oral and written communication and interpersonal skills
- Strong attention to detail
- Experience in Production QA, QC is desirable
- Experience in Visual Inspection is desirable
- Experience with Track Wise deviation and change‑management processes
- Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not sponsor work authorization or visas for this role
- Completion of Post‑Offer Exam or Completion of Work Simulation if applicable
- Ability to work overtime as requested
- Demonstrated strong oral and written communication and interpersonal skills
- Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred
- Demonstrated knowledge and understanding of pharmaceutical process and quality systems
- Knowledgeable with inventory management systems and deviations systems (e.g., SAP, Track Wise)
- Previous work with combination products or devices with experience with US/EU regulations and notified bodies
- Previous experience in GMP production environments
- Previous facility or area start‑up experience
- Knowledge of validation/qualification activities
- Demonstrated decision‑making and problem‑solving skills
- Strong attention to detail
- Proven ability to work independently or as part of a team to resolve issues
- Night shift:
The position will support a 24/7 operation, working a rotating twelve‑hour day shift schedule. During the onboarding phase, the role will work eight hours Monday‑Friday day shift, then transition to the rotating twelve‑hour day shift upon approval from supervision - Maintain qualifications and certifications for access to all supported areas required of the position
- Mandatory overtime may be required, planned and unplanned
- Applicant may work in various areas within the DAP and Warehouse buildings. Mobility requirements should…
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