- Responsible for adhering to safety rules and maintaining a safe work environment for both ones-self and others by supporting HSE corporate and site goals.
- Responsible for ensuring training is completed and remains in compliance.
- Communicates with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues.
- Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
- Advise Operations and support personnel on quality matters, while driving the site Quality culture.
- Ensures regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems.
- Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance.
- Performs daily documented Quality Checks.
- Perform sample collection, inspection, and delivery of samples to storage location and/or laboratory.
- Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise. PMX).
- Participate in self-led inspections and provide support during internal / external regulatory inspections.
- Ability to work cross functionally and work collaboratively with all levels of the organization.Basic Requirements:
- High School Diploma or equivalent
- 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.
- Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.
- 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.
- 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:
- May be required to respond to operational issues outside of core business hours / days.
- Applicant may work in various areas within the DAP and Warehouse buildings. Mobility requirements should be considered when applying for this position. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly -
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QA Floor Support - Durham, United States - Eli Lilly and Company
Description
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.
Eli Lilly RTP is a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to be part of Team Lilly and work with the latest formulation, isolator, and visual inspection technology.
The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Floor Support Supervisor. Responsibilities include providing QA oversight to GMP operations in the Parenteral equipment preparation, formulation, filling, and visual inspection areas. The QA Floor Support Specialist oversees production functions to achieve site goals while providing Quality oversight and ensuring compliance.
Key Objectives/Deliverables:
