Lead Process Technician - QA Floor

Position: Lead Process Technician - QA Floor Support
## Lead Process Technician - QA Floor Support Apply locations:
US:
Research Triangle Park NCtime type:
Full time posted on:
Posted Yesterday job requisition :
R-106162

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 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 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.
*
* 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.  + 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)  + Track Wise (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 / GED minimum
* Demonstrated relevant pharmaceutical experience in aseptic manufacturing
* 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 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 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.
** Additional Preferences:
*** Demonstrated strong oral and written communication and interpersonal skills.
* Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field…