Lead - Quality Assurance Floor Support Specialist; Nights

Role Summary

Lead - Quality Assurance Floor Support Specialist (Nights) based in Raleigh-Durham, North Carolina. Provide QA oversight for GMP operations in the Device Assembly and Packaging area, lead the QA Floor Support team, and mentor Operations and Support staff to ensure compliance and drive the site quality culture. This role supports multiple production functions and partners with cross-functional teams to achieve site goals on a rotating night shift.

• Adhere to safety rules and maintain a safe work environment by supporting HSE goals.
• Ensure training is completed and remains in compliance.
• Communicate with QA Floor Support Supervisor and Quality Representatives on quality and operational issues.
• Ensure adherence to good documentation practices and compliance with applicable procedures for Operations and Support personnel.
• Lead, mentor, and coach Operations and support personnel on quality matters, driving the site Quality culture.
• Maintain regular presence in device assembly and packaging areas to monitor GMP programs and quality systems.
• Assess and create deviations/observations that occur within the device assembly and packaging areas.
• Review and approve GMP documentation in support of daily operations such as Maintenance Action Plans, Return to Service and Release of equipment, area holds, spare parts consultation, work order assessments and issue resolution.
• Troubleshoot and provide QA systems support to reconcile issues in multiple systems (e.g., SAP, PMX, Track Wise, Smart Lab, GMARS, Coldstream, and others).
• Participate in self-led inspections and provide support during internal/external regulatory inspections.
• Effectively review and/or redline to ensure quality attributes are met (deviations/observations, procedures, production records, validation protocols, change controls, and engineering documents).
• Collaborate cross-functionally and work with all levels of the organization.

• Required: High School Diploma or equivalent
• Preferred: Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study
• Required: Completion of Post Offer Exam or Completion of Work Simulation if applicable
• 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
• Preferred: Ability to work overtime, as requested
• Preferred: Demonstrated strong oral and written communication and interpersonal skills
• Preferred: Demonstrated knowledge and understanding of manufacturing process and Quality Systems
• Preferred: Proficiency with inventory management systems and deviations systems (e.g., SAP, Track Wise)
• 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

• Strong knowledge of GMP, Quality Systems, and documentation practices
• Proficiency with SAP, Track Wise, PMX, Smart Lab, GMARS, and related systems
• Excellent problem-solving and decision-making abilities
• Effective cross-functional collaboration and communication
• Attention to detail and accuracy in documentation and records
• Ability to work independently and as part of a team
• Strong organizational and time-management skills; adaptable to a 24/7 operation and shift changes

• High School Diploma or equivalent
• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study (preferred)

• This position will support a 24/7 operation, working a rotating twelve (12) hour night shift schedule. During the project and onboarding phase, role will work eight (8) hours Monday-Friday dayshift, then transition to the rotating twelve (12) hour night shift upon approval from supervision/management.
• 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.
• Position is for night shift, but dayshift work may be required.
• Position may require a short duration assignment of 1-3 months in Indianapolis to establish specific device knowledge and establish global contacts.