Quality Assurance Floor Support Specialist -Visual Inspection
Eli Lilly
- Durham, NC
- Permanent
- Full-time
- Ensures regular presence in assigned parenteral areas to perform AQL inspections, manage sample collection/deliver to laboratories.
- Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
- Responsible for ensuring training is completed and remains in compliance.
- Communicates with QA Representative and QA Parenteral Associate Director 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.
- Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance.
- 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.
- High School Diploma or equivalent
- Demonstrated experience in GMP facility
- 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.
- Parenteral Inspection experience (automated, semi-automated and manual).
- Associate degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
- Strong understanding of quality systems in the inspection environment.
- Demonstrated strong oral and written communication and interpersonal skills to communicate to operators and management.
- Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.
- Strong attention to detail and demonstrated organizational skills.
- Basic computer skills including Microsoft Office products, (Excel, Word, PowerPoint, Outlook), inventory control (SAP), and electronic batch records (PMX)
- Ability to work cross functionally and work collaboratively with all levels of the organization.
- Proven ability to work independently or as part of a team to resolve issues.
- Shift Monday - Thursday or Tuesday - Friday, 10 Hours (Day Shift)
- Ability to work overtime, as requested.
- Ability to wear safety equipment (safety glasses, safety shoes, protective gloves, etc.) and follow site gowning requirements.
- Physical Demands: Light work that requires physical effort. Requires good communication skills, eye-hand coordination and manual skills. Occasionally requires force to raise, to load, and to push objects. Occasionally requires movements of the body like to incline, to climb, to kneel, to bend, to rise, and to walk down stairs.
- Must pass an annual vision test and be free of color blindness.
- Must be equivalent to 20/20 correctable close vision acuity