Sterile Compounding Trainer (503A / 503B Facility)

Job Title : Sterile Compounding Trainer (503A / 503B Facility)

Location : Ohio, United States

Experience : 3 5 Years

Duration : 12+ Months Contract

Job Summary :

We are looking for a skilled Sterile Compounding Trainer to support ongoing training and qualification activities within a 503A or 503B sterile compounding facility . This role is vital for maintaining regulatory compliance and ensuring personnel competency in aseptic techniques, sterile compounding practices, and cleanroom behavior. The ideal candidate brings a strong foundation in USP

, cGMP standards , and FDA 503A / 503B regulations, along with proven experience in hands-on sterile compounding and employee training.

The Sterile Compounding Trainer will work closely with Quality Assurance and Operations teams to design, implement, and maintain robust training programs that uphold the highest standards of sterility, product quality, and patient safety.

Key Responsibilities :

Develop, deliver, and maintain comprehensive training programs in compliance with USP

, FDA 503A / 503B regulations , and internal Standard Operating Procedures (SOPs) .

Conduct onboarding, refresher, and qualification training sessions for compounding personnel covering :

Hand hygiene, garbing, and sterile gloving techniques

Material transfer and staging procedures

Kitting and preparation workflows

Cleaning, disinfection, and environmental control practices

Weighing, measuring, and mixing of components

Aseptic compounding and sterile transfer methods

Filling, capping, labeling, and final product handling

Perform initial qualifications and ongoing competency assessments to ensure operator proficiency.

Maintain accurate and complete training documentation, qualification records, and certification logs in compliance with quality and regulatory requirements.

Partner with Quality Assurance to review and update training content as regulations or internal procedures evolve.

Provide support during audits and regulatory inspections , ensuring training records and procedures are audit-ready.

Act as a Subject Matter Expert (SME) for aseptic techniques, offering guidance and coaching to compounding staff.

Drive continuous improvement initiatives focused on training effectiveness, operational consistency, and sterility assurance.

Ensure adherence to all environmental and safety protocols within controlled cleanroom environments.

Qualifications : Required :

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology , or a related scientific discipline; or equivalent professional experience.

3 5 years of hands-on experience in a 503A or 503B sterile compounding facility .

Deep understanding of USP

, cGMP , and aseptic processing requirements .

Proven ability to train, mentor, or supervise sterile compounding staff.

Strong attention to detail, excellent communication , documentation , and organizational skills .

Preferred :

PTCB Sterile Compounding Certification or other recognized formal training in sterile compounding.

Familiarity with USP

and handling of hazardous drugs.

Experience working within cleanroom environments and understanding environmental monitoring programs .

Working Conditions :

Work is performed within controlled cleanroom environments (ISO 5 8) .

Requires full compliance with gowning, gloving, mask, and aseptic garbing procedures.

May involve standing for extended periods , repetitive tasks, and occasional lifting of up to 25 lbs .

Must adhere strictly to facility hygiene and contamination control standards.