Technician - QA Floor Support

Role Summary

The Quality Assurance Floor Support Specialist is 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, and overseeing production functions to achieve site goals while ensuring quality compliance.

Responsibilities

• Responsible for adhering to safety rules and maintaining a safe work environment by supporting HSE goals.
• Ensure training is completed and remains in compliance.
• Communicate with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues.
• Ensure adherence and understanding of good documentation practices and compliance with applicable procedures for Operations and Support personnel.
• Advise Operations and support personnel on quality matters, while driving the site Quality culture.
• Maintain regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs, and quality systems.
• Review and approve GMP documentation in support of daily operations (electronic batch records, paper logbooks, cleaning, procedures versus performance).
• Perform 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 (e.g., SAP, Darwin LIMS, TrackWise, PMX).
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Ability to work cross-functionally and collaboratively with all levels of the organization.

Qualifications

• Required: High School Diploma or equivalent
• Required: Legally authorized to work in the United States; no visa sponsorship expected
• Required: Completion of Post Offer Exam or Work Simulation if applicable
• Required: Ability to work overtime, as requested
• Preferred: Bachelor‚Äôs degree in a science, engineering, computer, or pharmaceutical-related field
• Preferred: Demonstrated knowledge of pharmaceutical processes and Quality Systems
• Preferred: Knowledge of inventory management and deviations systems (e.g., SAP, TrackWise)
• Preferred: Experience with combination products or devices and familiarity with US/EU regulations and notified bodies
• Preferred: Experience in GMP production environments and facility or area startup
• Preferred: Knowledge of Validation / Qualification activities
• Preferred: Strong decision-making, problem-solving skills, attention to detail
• Preferred: Ability to work independently or as part of a team to resolve issues

Skills

• Strong oral and written communication and interpersonal skills
• Knowledge of inventory management systems and deviations systems (e.g., SAP, TrackWise)
• GMP and QA documentation practices; analytical and problem-solving abilities
• Cross-functional collaboration and ability to work with all organizational levels

Education

• High School Diploma or equivalent (required)
• Bachelor‚Äôs degree in science/engineering/computer/pharmaceutical field (preferred)

Additional Requirements

• May be required to respond to operational issues outside core business hours
• Mobility to work in various areas within the DAP and Warehouse buildings; consider mobility requirements when applying
• Accommodation requests for resume submission permitted during application process