Field Support Quality

Essential Job Functions:

• Ensures the center remains inspection-ready by performing pre-inspection reviews, providing training, and ensuring compliance with all regulatory requirements and the quality management system.
• Complies with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA), FDA, European Union (EU), Plasma Protein Therapeutics Association (PPTA), customer, and other federal, state, and local regulatory, company policies and procedures.
• Acts as backup for centers without a Quality Manager, fully overseeing and managing all quality-related responsibilities, including managing and supporting center quality staff.
• Represents corporate leadership during audits, providing responsive direction and guidance throughout the inspection process.
• Facilitates corrective and preventive action plans (CAPAs) for findings from internal and external audits, ensuring timely resolution.
• Travels across centers to provide hands-on support and ensures adherence to quality standards, policies, and standard operating procedures (SOPs).
• Acts as a key resource for center staff, addressing quality-related concerns and implementing solutions.
• Analyzes deviation reports, audits data, and tracks systems to identify systemic issues and areas for improvement.
• Acts as liaison between the Regional Quality Manager and center operations on quality matters.
• Conducts hands-on observations during center visits to assess staff performance, training efficacy, and adherence to SOPs.
• Identifies and reviews quality and safety risks for assigned centers and works with center and remote leadership to develop appropriate actions.
• Interprets and applies SOPs, ensuring SOP revisions are implemented correctly, efficiently, and effectively.
• Ensures collected products and samples are stored and maintained under established regulations and standard operating procedures.
• Fosters effective communication across all organizational levels, building partnerships that encourage innovation and participation in problem-solving strategies.

Other Duties

• Performs additional duties as directed by management.

Qualifications, Experience, and Education

• A Bachelor’s degree in Science is preferred. Other combinations of education and experience may be considered.
• 1-2 years’ supervisory experience is preferred.
• Demonstrated expertise in interpreting Current Good Manufacturing Practices (cGMPs), FDA regulations, and SOP development and understanding of quality principles.
• Excellent knowledge of applicable company and departmental policies and procedures and willingness to learn and follow new policies or procedures.
• Strong knowledge of office software products, including word processing, spreadsheet, and presentation software applications.
• Excellent critical reasoning, decision-making, and problem-solving skills to analyze situations, determine risks, find solutions to prevent future issues, and resolve recurring defects.
• Strong organizational skills and attention to detail to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities to support changing company objectives.
• Strong leadership, training, written and verbal communication, and interpersonal and presentation skills to drive results.
• Ability to travel frequently and long distance, up to 85% of the time.
• Ability to lift up to 25 pounds routinely and up to 50 pounds occasionally.