Technician - QA Floor Support

Role Summary

The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Floor Support Supervisor. Provides QA oversight to GMP operations in the Parenteral equipment preparation, formulation, filling, and visual inspection areas. Oversees production functions to achieve site goals while providing quality oversight and ensuring compliance. Location: Raleigh-Durham, North Carolina.

Responsibilities

• Responsible for adhering to safety rules and maintaining a safe work environment for both oneself 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.

Qualifications

• Required: High School Diploma or equivalent
• Required: Authorized to work in the United States on a full-time basis. Lilly will not provide sponsorship or support for 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.
• Required: Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• Required: Ability to work overtime, as requested.
• Preferred: Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study.
• Preferred: Demonstrated strong oral and written communication and interpersonal skills.
• Preferred: Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.
• Preferred: Knowledgeable with inventory management systems and deviations systems (i.e., SAP, TrackWise, etc.)
• Preferred: Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
• Preferred: Previous experience in GMP production environments.
• Preferred: Previous facility or area start up experience.
• Preferred: Knowledge of Validation / Qualification activities.
• Preferred: Demonstrated decision making and problem-solving skills.
• Preferred: Strong attention to detail
• Preferred: Proven ability to work independently or as part of a team to resolve issues.

Skills

• Strong oral and written communication and interpersonal skills.
• Ability to work cross-functionally and collaboratively with all levels of the organization.
• Strong attention to detail and accuracy.
• Problem-solving and decision-making abilities.

Education

• High School Diploma or equivalent (Required).
• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field (Preferred).

Additional Requirements

• May be required to respond to operational issues outside of core business hours / days.
• Mobility requirements: applicant may work in various areas within the DAP and Warehouse buildings.