Documentation and Training Specialist

Catalent Pharma Solutions; Strathroy; On-site; CAD 70,000 - 85,000; Full time

Job summary

A global contract development organization is seeking a Documentation and Training Specialist in Strathroy, Ontario. This role involves maintaining training programs to comply with GMP standards, conducting training sessions, and managing documentation. The ideal candidate has a relevant degree and experience in regulated environments, particularly in the pharmaceutical sector. Comprehensive benefits and opportunities for professional development are offered.

Benefits

Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)

Group Retirement Savings

Paid Time Off Programs

Employee Reward & Recognition programs

Professional development opportunities

Qualifications

• 2+ years of experience in Quality, Operations, or related field.
• Experience in designing and delivering effective training programs.
• Experience in a regulated manufacturing environment, preferably pharmaceutical.

Responsibilities

• Organize and conduct training sessions and maintain related files.
• Schedule and deliver classroom GMP training and measure effectiveness.
• Manage the controlled document library and ensure GMP compliance.

Skills

Training and development

GMP Compliance

Communication skills

Education

Diploma or Bachelor’s Degree in Science, Education, or related field

Tools

TrackWise

ComplianceWire Learning Management System

Job description

Documentation and Training Specialist

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent supports product development, launch, and full life-cycle supply for pharma, biotech, and consumer health customers, with a global presence across more than 40 sites and thousands of scientists and technicians. This role is part of the Strathroy, Ontario site startup for Catalent’s Zydis technology, and involves activities from installation and qualification to regulatory approval and commercial manufacturing. If you’re seeking meaningful work, opportunities for growth, and the excitement of building something extraordinary, we want to hear from you.

The Documentation and Training Specialist will maintain the company’s training programs to comply with GMP, Health, Safety and Environmental Compliance. The role includes organizing and conducting training sessions, maintaining related files and databases, and ensuring compliance, effectiveness, and operational excellence.

Current work hours are Monday-Friday from 8AM to 4:30PM. This position is 100% on-site at the Adair facility in Strathroy, Ontario. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

• General site administrator of the TrackWise application.
• General site administrator and Subject Matter Expert of the ComplianceWire Learning Management System (LMS) application.
• Maintain training syllabi, update training database, and maintain employee training records.
• Schedule and deliver classroom GMP training and measure effectiveness of learning.
• Monitor and make recommendations to training-related procedures to ensure GMP compliance.
• Manage the controlled document library in EDMS (Electronic Document Management System) and other quality systems, ensuring GMP documents are prepared, authorized, and rigorously controlled.
• Review quality documents for appropriateness and accuracy for transfer into EDMS.
• Perform other duties as required.

The Candidate

• Diploma or Bachelor’s Degree required in Science, Education, or related field. Adult learning techniques are an asset.
• 2+ years of experience in Quality, Operations, or related field.
• Experience working in a complex regulated manufacturing environment.
• Experience in training and development, preferably within the pharmaceutical industry or a similar regulated environment; experience in designing and delivering effective training programs, curriculum development, and training delivery methodologies is desirable; experience with FDA and HPFBI inspections is desirable.
• Currently Catalent does not participate in the Ontario Immigrant Nominee Program (OINP).
• Candidates with non-Canadian credentials must provide an evaluation confirming Canadian equivalency (e.g., ACESC/WES).
• While performing the responsibilities of the job, the employee may talk and hear, sit and use hands, and perform manual tasks. Visual acuity required for close vision.

Why You Should Join Catalent

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
• Group Retirement Savings – Registered Pension Plan (RPP) with employer contributions
• Paid Time Off Programs including vacation, banked time & personal time
• Employee Reward & Recognition programs
• Opportunities for professional and personal development, including tuition reimbursement

Catalent offers rewarding opportunities to further your career. Join the global drug development and delivery leader to help bring over 7,000 life-saving and life-enhancing products to patients worldwide. Catalent is an equal opportunity employer and does not discriminate based on any characteristic protected by local law. If you require reasonable accommodation for any part of the application or hiring process, please email [e-mail] with your request and job details.

Notice to Agency and Search Firm Representatives: Catalent is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency without a valid written signed search agreement will become the property of Catalent, and no fee will be paid for unsolicited referrals.