Technician - Process Quality Assurance Floor Support (Night Shift)

Role Summary

Technician - Process Quality Assurance Floor Support (Night Shift) serves as a member of the QA Floor Support team, providing QA oversight to GMP operations in Parenteral equipment preparation, formulation, filling, and visual inspection areas. The role ensures production functions align with site goals while upholding quality oversight and compliance.

Responsibilities

• Responsible for adhering to safety rules and maintaining a safe work environment for 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: Legally authorized to be employed in the United States (no visa sponsorship anticipated)
• 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
• 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 relevant US/EU regulations
• Preferred: Experience in GMP production environments
• Preferred: Facility or area start-up experience
• Preferred: Knowledge of Validation / Qualification activities
• Preferred: Strong decision making and problem-solving skills
• Preferred: Strong attention to detail; ability to work independently or as part of a team

Skills

• Strong oral and written communication
• Interpersonal skills
• Cross-functional collaboration
• Quality systems and GMP awareness

Education

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

Additional Requirements

• Night shift: Support a 24/7 operation with rotating twelve-hour shifts. Onboarding may start with eight-hour Monday-Friday day shift before transitioning to the rotating schedule.
• Mobility: May work in various areas within the DAP and Warehouse buildings; mobility requirements should be considered when applying.