Documentation and Training Specialist

Catalent; Strathroy-Caradoc; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading global contract development organization is seeking a Documentation and Training Specialist in Strathroy, Ontario. The successful candidate will manage training programs, ensure compliance with GMP standards, and support the launch of innovative manufacturing technology. This role offers opportunities for professional growth and development within a dedicated team at the forefront of pharmaceutical manufacturing.

Benefits

Comprehensive Benefit Package

Retirement Savings Plan with employer contributions

Paid Time Off

Employee Recognition programs

Tuition reimbursement

Qualifications

• 2+ years of experience in Quality, Operations, or related field.
• Experience in a complex regulated manufacturing environment.
• Previous experience in training and development within the pharmaceutical industry is desirable.

Responsibilities

• Maintain training programs to comply with GMP and HSE standards.
• Organize and conduct training sessions.
• Monitor and recommend training procedures to ensure compliance.

Skills

Training and development

GMP compliance

Quality document management

Adult learning techniques

Education

Diploma or Bachelor’s Degree in Science or Education

Tools

ComplianceWire Learning Management System

TrackWise

EDMS (Electronic Document 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 is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. 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. We’re bringing this mission to Strathroy, Ontario, with the launch of our new manufacturing facility on Adair Blvd. This site marks a pivotal expansion of Catalent’s Zydis technology, a globally renowned, fast-dissolve oral dosage form that has transformed the lives of millions of patients worldwide. This is your opportunity to join a dedicated team at the forefront of pharmaceutical manufacturing. At Adair, you’ll play a vital role in the startup of a site built for innovation and excellence, 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 overall training programs to comply with GMP, Health, Safety and Environmental Compliance. The Documentation and Training Specialist will organize and conduct training sessions, as required, and maintain related files, databases and applicable materials while 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.
• Monitors and makes recommendations to training related procedures to ensure compliance to GMP.
• Manage the controlled document library in EDMS (Electronic Document Management System) and other quality systems, ensuring documents required as a part of GMP are prepared, authorized, and rigorously controlled.
• Review Quality documents for their 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 technique is an asset.
• 2+ years of experience in Quality, Operations, or related field.
• Experience working in a complex regulated manufacturing environment.
• Previous experience in training and development, preferably within the pharmaceutical industry or a similar regulated environment, is highly desirable; experience of designing and delivering effective training programs, curriculum development, and training delivery methodologies is highly desirable; experience of preparation, involvement relating to 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 the Canadian equivalency of the credentials as determined by the Alliance of Credential Evaluation Services of Canada (ACESC) such as WES.
• While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required. The employee is required to stand, walk, reach with arms and hands, bend or twist, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include 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 & growth including tuition reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Disability accommodations: If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email and including the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a Catalent employee and routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.