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
KEY RESPONSIBILITIES
General GMP Training
* 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.
Solid Oral Dosage (SDF) Training
* 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
EDUCATION:
Bachelor's degree in Life Sciences, Pharmacy, Microbiology, Engineering, or a related scientific
discipline required. Equivalent experience may be considered.
EXPERIENCE:
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
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