Pharmaceutical Aseptic Processing Trainer

Hims & Hers-posted 10 days ago
Full-time • Mid Level
Gilbert, AZ
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We are seeking a highly experienced and knowledgeable Pharmaceutical Aseptic Processing Trainer to lead training and development programs for aseptic processing personnel within our sterile compounding facility. This role plays a critical part in ensuring that compounding staff are well-equipped with the technical knowledge and practical skills required to maintain compliance with cGMP, USP <797>/<800>, and FDA 503A/503B regulatory requirements. The ideal candidate will bring deep subject-matter expertise in sterile pharmaceutical manufacturing and aseptic processing, with a proven track record in hands-on training and evaluation of compounding operators. This position will collaborate closely with Quality Assurance, Operations, Learning, and Compliance teams to maintain the highest standards in product integrity and patient safety.

  • Develop, deliver, and continuously improve comprehensive training programs for aseptic technique, cleanroom behavior, environmental monitoring practices, gowning, sterilization, visual inspection and compounding procedures.
  • Conduct hands-on training and assessments for new hires and experienced staff in both simulated and live sterile compounding environments.
  • Lead ongoing competency evaluations and retraining initiatives to ensure continuous compliance with regulatory standards and internal SOPs.
  • Collaborate with QA and Operations to investigate deviations, identify training-related root causes, and implement corrective actions through targeted education.
  • Maintain up-to-date training records and documentation in compliance with FDA 503A/503B requirements, USP guidelines, and cGMP practices.
  • Stay informed on regulatory changes and integrate new industry best practices into training curricula.
  • Provide mentorship and technical guidance to aseptic operators and pharmacy technicians to elevate team performance and product quality.
  • Ability to work primarily day shift hours, with flexibility to cover night shift hours as needed to support our 24/7 pharmacy operation.
  • Minimum 5 years of direct experience working in sterile pharmaceutical manufacturing , 503B outsourcing facilities , or 503A pharmacy compounding environments, with hands-on aseptic processing responsibilities in manual and semi-automated filling techniques.
  • Bachelor’s degree required , preferably in Pharmaceutical Sciences, Microbiology, Biology, Chemistry, Quality Assurance, or a closely related field.
  • Minimum 3 years of experience in training and evaluating aseptic processing personnel or sterile compounding staff.
  • Experience delivering hands-on training in both individualized (1:1) and group/classroom environments preferred.
  • Deep understanding of USP <797>, USP <800>, cGMP, and FDA 503A/503B regulations.
  • Proven expertise in cleanroom protocol, contamination control, gowning, and aseptic techniques
  • Demonstrated experience applying quality assurance techniques such as root cause analysis, deviation/investigation management, CAPA processes, and documentation best practices.
  • Experience in developing training SOPs, competency checklists, and aseptic simulation media fill validation.
  • Strong communication skills with the ability to teach complex topics to diverse audiences.
  • Background in auditing or regulatory inspections (e.g., FDA, BOP, PCAB) is a plus.
  • Competitive salary & comprehensive health benefits including medical, dental & vision
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