GMP and Onboarding Specialist

Stokes Pharmacy•Mount Laurel Township, NJ

5d•$28•Onsite

About The Position

Epicur Pharma is seeking a detail-oriented and compliance-driven GMP & Onboarding Specialist to support training, onboarding, and regulatory compliance initiatives within our cGMP manufacturing facility. This role is responsible for ensuring new hires and existing employees are effectively onboard and trained in accordance with cGMP, FDA, State and company standards. The ideal candidate combines strong knowledge of pharmaceutical regulations with structured onboarding experience, excellent documentation practices, and the ability to foster a culture of quality, compliace and operational excellence.

Requirements

Bachelor’s degree in Life Sciences, Quality, Education, or related field (or equivalent experience).
3+ years of experience in a GMP-regulated pharmaceutical or biotechnology environment.
Strong understanding of cGMP requirements, FDA regulations, and documentation practices.
Experience delivering compliance training or managing onboarding programs.
Working knowledge of Learning Management Systems (LMS).
Strong organizational, communication, and facilitation skills.
Strategic and analytical thinking

Responsibilities

Deliver cGMP training programs for manufacturing, quality, engineering, warehouse, and support personnel.
Ensure all training content aligns with current FDA regulations, ICH guidelines, and internal SOPs.
Maintain compliance with regulatory requirements including 21 CFR Parts 210 & 211.
Monitor training completion and compliance metrics to ensure audit readiness.
Support regulatory inspections and internal audits by providing training documentation and records.
Assist with investigations, CAPAs, and change controls impacting training requirements.
Coordinate and facilitate structured onboarding programs for new hires.
Partner with HR and department leaders to ensure smooth integration into GMP-regulated operations.
Develop onboarding materials, checklists, and qualification pathways. Ensure timely assignment and completion of required GMP curricula.
Track onboarding milestones and provide progress updates to management.
Create and update curricula, assessments, and qualification matrices.
Ensure job role–based training assignments are aligned with SOPs and operational needs.
Support periodic training effectiveness reviews and continuous improvement initiatives.
Identify training gaps and recommend improvements to enhance compliance and workforce capability.
Promote a culture of quality, accountability, and continuous improvement.
Support cross-functional collaboration between Quality, Manufacturing, and HR.
Other duties as assigned.