Lead QA Tech - Parenteral

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Quality Assurance Floor Support Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Operations activities.
The QA Floor Lead Tech is responsible for providing daily support and oversight to GMP operations in Raleigh-Durham North Carolina.  The QA Floor Support Lead Tech works as a team member supporting multiple production functions (formulation, filling, and visual inspection), from operations to maintenance, to achieve site goals while providing Quality oversight and guidance. 

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.

  • monitors for, retrieves, and completes review of all paperwork in need of quality review in each area supported and coordinates delivery to the associated area when complete.

  • Supports 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

• Performs 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)

  • TrackWise (compliance

  • Veeva (controlled document repository)

  • GMARS (calibration and maintenance system)

  • And other systems as required

• Work within team to ensure all manufacturing areas receive QA support needed to maintain daily operations

• Reviews GMP documents (e.g., Procedures, Protocols, and Production Record Instructions)

Basic Requirements:

• High school diploma or equivalent

• Demonstrated relevant pharmaceutical experience in aseptic manufacturing

Additional Preferences:

• Associates 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 TrackWise Deviation and Change Management processes

Additional Information:

• This position will support a 24/7 operation, working a rotating twelve (12) hour day shift schedule.  During the project and onboarding phase, role will work eight (8) hours Monday-Friday day shift, then transition to the rotating twelve (12) hour day shift stated above upon approval from Supervision/Management.

• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

• Completion of Post Offer Exam or Completion of Work Simulation if applicable

• Maintain qualifications and certifications for access to all supported areas required of the position.

• Mandatory overtime may be required, planned and unplanned.

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