COMPANY OVERVIEW
Halo Pharmaceutical is a technology-focused contract development and manufacturing organization (CDMO) specializing in solid, semi-solid, and liquid dosage forms, with differentiated expertise in controlled substances manufacturing. With facilities in the United States and Canada, Halo supports leading pharmaceutical companies through high-quality manufacturing,operational excellence, and customer-focused solutions.
Join a growing CDMO where your leadership, operational expertise, and ability to drive performance will directly influence site success and customer satisfaction.
POSITION OVERVIEW
Halo Pharmaceutical is seeking a highly motivated and experienced GMP Training Specialist to join our Quality department within a dynamic cGMP pharmaceutical environment.
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 Parts210/211, 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.
Aseptic Fill-Finish Training
- Design, develop, and maintain aseptic technique training curricula for personnel operating in classified clean-room environments (Grade A/B and equivalent ISO classifications).
- Delivering qualification training and conduct initial and periodic gowning qualification,aseptic behavior observation, and re-qualification of personnel, including support of aseptic process simulations (media fills).
- Develop and update training content reflecting current EU GMP Annex 1 requirements,including Contamination Control Strategy (CCS) principles, environmental monitoring expectations, and personnel behavior in clean-rooms.
- Support the training elements of the site Contamination Control Strategy, ensuring training records demonstrate ongoing personnel qualification for aseptic operations.
Cross-Functional / Program Support
- Incorporate ISO 13485 quality management system and risk management training requirements where applicable to combination products or device-related components.
- Partner with Manufacturing, Quality Assurance, Microbiology, and Validation teams to identify training needs arising from deviations, CAPAs, process changes, equipment introductions, and audit/inspection observations.
- Develop training materials, SOP walk-throughs, job aids, and competency assessments across dosage forms; ensure materials remain current with SOP revisions and regulatory updates.
- Conduct training needs assessments and gap analyses; evaluate training effectiveness through observation, assessments, and quality performance metrics (e.g., deviation trends,environmental monitoring excursions, batch record errors).
- Support internal, customer, and regulatory audits and inspections by providing training records and demonstrating program compliance across all manufacturing areas.
- Facilitate on-boarding training for new hires and contractors prior to unsupervised access to manufacturing or classified areas.
- Track and trend training compliance metrics and report status to Quality and Manufacturing leadership.
- Contribute to CAPA investigations where corrective actions involve training or human performance factors, framing recommendations as system and process improvement opportunities.
- Maintain personal qualification and competency as a GMP trainer across dosage forms,including periodic re-qualification and continuing education on evolving regulatory expectations.
- Perform other functions as required or assigned.
POSITION QUALIFICATIONS
- Excellent verbal and written communication and facilitation skills with the ability to present effectively within all levels of the organization.
- Flexibility to support multiple shifts and training sessions across manufacturing operations.
- Strong understanding of cGMP principles across dosage forms, including solid oral dosage manufacturing and aseptic/sterile processing environments.
- Hands-on knowledge of solid oral dosage manufacturing equipment and processes (tablet compression, encapsulation, coating, granulation, blending).
- Hands-on experience with gowning qualification, aseptic behavior observation, and environmental monitoring expectations in classified clean room environments.
- Working knowledge of 21 CFR Parts 210 and 211, EU GMP Annex 1, and general GMP training program design and delivery.
- Familiarity with 21 CFR 820 and ISO 13485 quality management system requirements, particularly for combination products or device-related components.
- Experience with Master Control and training record documentation practices.
- Experience with quality systems and software such as TrackWise, and SAP is a plus.
- Ability to work independently with minimal supervision in a fast-paced, regulated, multi-dosage-form environment.
- Adherence to regulatory/in-house requirements (safety, housekeeping, cGMP, GDP, documentation) when performing assigned activity. Use of personal protective equipment and adherence to clean-room gowning and behavior standards where applicable.
- Ability to work collaboratively with cross-functional teams to ensure successful outcomes.
- Strong attention to detail and ability to produce accurate, compliant training documentation.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint). Certification or formal training in adult learning principles, instructional design, or training-the-trainer programs is a plus.
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
WHY JOIN HALO PHARMA
- Opportunity to play a key leadership role within a growing pharmaceutical CDMO
- High level of visibility and direct impact on operational and business performance
- Collaborative and team-oriented culture
- Opportunity to lead operational improvements and influence site performance
- Fast-paced environment with strong professional growth potential
Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background.
Halo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Job Type: Temporary
Pay: $38.50 per hour
Work Location: In person
