Technician - Process Quality Assurance Floor Support (Night Shift)

Job Responsibilities

• Responsible for adhering to safety rules and maintaining a safe work environment for both ones-self 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.
• Able to work cross functionally and work collaboratively with all levels of the organization.

Basic Requirements

• High School / GED minimum
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• Ability to work overtime, as requested.

Additional Preferences

• Demonstrated strong oral and written communication and interpersonal skills.
• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.
• Knowledgeable with inventory management systems and deviations systems, (i.e. SAP, TrackWise, etc.)
• Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
• Previous experience in GMP production environments.
• Previous facility or area start up experience.
• Knowledge of Validation / Qualification activities.
• Demonstrated decision making and problem-solving skills.
• Strong attention to detail
• Proven ability to work independently or as part of a team to resolve issues.