GMP Training Specialist
$72,800–$80,080 year
On-siteWhippany, New Jersey, United States
Job Summary
Design, develop, and maintain site-wide cGMP training programs for new hires, contractors, and existing personnel across manufacturing, quality, and support functions. Deliver GMP fundamentals including good documentation practices, data integrity, and change control awareness while administering the Master Control for curriculum assignments and effectiveness tracking. Create curricula for solid oral dosage operations covering granulation, blending, compression, encapsulation, and coating, along with equipment-specific procedures for tablet presses, encapsulators, and granulators. Support training on in-process controls, batch record execution, and cleaning validation within solid dosage suites. Ensure all content complies with 21 CFR Parts 210/211, 820, EU GMP Annex 1, and ISO 13485 to sustain audit readiness.
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Microbiology, Engineering, or a related scientific discipline
- Minimum of 3-5 years of experience in pharmaceutical or biopharmaceutical manufacturing
- Direct experience in solid oral dosage manufacturing (e.g., compression, encapsulation, coating)
- Direct experience in aseptic fill-finish or sterile drug product operations
- Prior experience developing and delivering technical or compliance training programs
- Agreement to receive calls, Al-generated calls, text messages, or emails from Synerfac Technical Staffing and our contracted partners
Desired Qualifications
- Experience as a gowning qualification assessor
- Experience as an aseptic behavior observer
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