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)
- 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 / 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 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.
Additional Preferences:
- 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.
- Strong attention to detail
- Proven ability to work independently or as part of a team to resolve issues.
Additional Information:
- Night shift: The position will support a 24/7 operation, working a rotating twelve (12) hour day shift schedule. During the 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.
- 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 be considered when applying for this position.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$28.84 - $46.54
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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