Lead Process Technician - QA Floor Support

Eli Lilly and Company • Research Triangle Park, NC

71d • $29 - $47 • Onsite

About The Position

The Lead Quality Assurance Floor Support Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of the site's Parenteral Operations activities. 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, and visual inspection), from operations to maintenance, to achieve site goals while providing Quality oversight and guidance.

Requirements

• High School / GED minimum
• Demonstrated relevant pharmaceutical experience in aseptic manufacturing
• 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
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• Ability to work overtime, as requested.

Nice To Haves

• Associates degree in a science, engineering, computer, or pharmaceutical related field of study, preferred
• 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, (i.e. SAP, TrackWise, etc.)
• 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.
• Proven ability to work independently or as part of a team to resolve issues.

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)

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED