GMP and Onboarding Specialist

Job Description

Job Description

Why Stokes?

Stokes Healthcare is a privately-owned business comprised of three divisions: Stokes Pharmacy (503A pharmacy), Epicur Pharma (503B facility) and STEP labs. The these divisions operate out of separate facilities in Mount Laurel, NJ, following different regulations and are guided by different principles.

Stokes Pharmacy was founded in 1975. The pharmacy formulates custom prescription medicines for both humans and animals. The business has grown from a small, hometown operation in Medford, New Jersey, to a respected pharmacy serving the entire U.S., enabled by sophisticated online ordering and overnight shipping capabilities.

In 2016, Stokes Healthcare built a world-class facility (which became Epicur Pharma), as a testament to the commitment to providing the highest level of quality. Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations followed by commercial manufacturers.

Epicur Pharma is proud to be a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. Epicur products are distributed directly to veterinary hospitals from our manufacturing facility and offered through Stokes Pharmacy for individual patient prescriptions.

STEP Labs is a GMP-compliant laboratory that delivers accurate, reliable analytical testing for manufactured pharmaceutical products. Equipped with advanced instrumentation and operated under strict regulatory standards, STEP Labs provides comprehensive services in microbiological and chemistry analysis with a focus on quality, data integrity, and timely results.

Stokes Healthcare has built a reputation for unwavering quality and superb service by holding fast to the founders’ commitment to traditional craftsmanship, combined with today’s most advanced knowledge and technologies. In a field where many corporate-owned pharmacies try to compete on price, Stokes has always put safety and quality first because patients’ lives depend on it.

At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, vacation and personal time, and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the NJ shore.

Salary: Starting at $28 hourly depending upon experience plus twice yearly bonuses.

Summary/Objective

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.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• 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.

Required Education and Experience

• 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

Eligibility Qualifications

It may be necessary to work extended hours as needed.

Competencies

• Regulatory knowledge and attention to detail
• Strong documentation and audit readiness mindset
• Excellent presentation and facilitation skills
• Cross-functional collaboration
• Ability to translate regulations into practical application
• Data-driven decision making

Supervisory Responsibility

This position does not have supervisory responsibilities.

Work Environment

• Manufacturing and office environment requiring adherence to gowning and PPE requirements.
• May require periodic flexibility to support shift-based onboarding.

Language Skills

Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.

Mathematical Skills

Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.

Reasoning Ability

Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• May sit, stand, stoop, bend and walk intermittently during the day.
• May sit or stand seven (7) to ten (10) hours per day.
• Finger dexterity to operate office equipment required.
• May need to lift up to 25 pounds, on occasion

Position Type and Expected Hours of Work

This is a full-time position. Because of the nature of the business, work schedules may vary at times.

Travel

No travel is expected for this position at this time however, this could change

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.

AAP/EEO Statement

Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.