GMP Training Specialist

A contract development and manufacturing organization that specializes in producing topical, semi-solid, and liquid pharmaceutical products for both prescription and over-the-counter markets. It supports clients through formulation, scale-up, manufacturing, and packaging, with a strong focus on quality, regulatory compliance, and speed to market.

The GMP Training Specialist is responsible for designing, delivering, and maintaining current Good Manufacturing Practice (cGMP) training programs across the site's manufacturing operations, including solid oral dosage (tablet and capsule) production and aseptic fill-finish operations, as well as general GMP training for all personnel. This role ensures that training content and delivery methods comply with 21 CFR Parts 210 and 211, 820, EU GMP Annex 1 (for sterile/aseptic operations), and ISO 13485 requirements.

The position plays a critical role in building a qualified, compliance-competent workforce across dosage forms and sustaining audit and inspection readiness.

Location:

100% onsite - 30 N. Jefferson Road, Whippany, NJ

• Design, develop, and maintain site-wide general cGMP training programs (21 CFR Parts 210/211, 820 and EU Annex
  1) for new hires, contractors, and existing personnel across manufacturing, quality, and support functions.
• Deliver GMP fundamentals training, including good documentation practices (GDP), data integrity, personnel hygiene, and change control awareness.
• Maintain and administer the Master Control, including curriculum assignment, records retention, and training effectiveness tracking across all departments.

• Design and deliver training curricula for solid oral dosage manufacturing operations, including granulation, blending, compression, encapsulation, coating, and packaging.
• Develop training content on equipment-specific operation, cleaning, and changeover procedures for tablet presses, encapsulators, coating pans, granulators, and blenders.
• Support training related to in-process controls, batch record execution, and deviation prevention within solid dosage manufacturing suites.
• Train personnel on cleaning validation and equipment changeover requirements specific to solid dosage manufacturing areas.

$35.00 - $38.50/hr

Bachelor's degree in Life Sciences, Pharmacy, Microbiology, Engineering, or a related scientific discipline required. Equivalent experience may be considered.

Minimum of 3-5 years of experience in pharmaceutical or biopharmaceutical manufacturing, with direct experience in solid oral dosage manufacturing (e.g., compression, encapsulation, coating) and/or aseptic fill-finish or sterile drug product operations. Prior experience developing and delivering technical or compliance training programs is required. Experience as a gowning qualification assessor, aseptic behavior observer, is a plus