Quality Compliance, Documentation and Training Specialist

Catalent -


Full job description

Position Summary

The Quality Compliance, Documentation and Training Specialist will maintain the company’s overall training programs to comply with GMP, Health, Safety and Environmental Compliance and overall site operational readiness and effectiveness. The Specialist will be responsible for the maintenance of the Company’s Learning Management System as well as the administration, development, and organization of the education and training programs.

The Specialist will be responsible for the maintenance of the Company’s Electronic Data Management System (EDMS). In addition, the Specialist will organize and conduct training sessions, as required, and maintain related files, databases and applicable materials while ensuring compliance, effectiveness, and operational excellence.

This is an exciting opportunity to play a pivotal role in developing the strategy for our new pharmaceutical site and shape the future of our operations in North America.

Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute lunch.

The Role

General site administrator and Subject Matter Expert in the ComplianceWire Learning Management System (LMS) application

General site administrator in the TrackWise deviation management application

Maintains training syllabi, updates training database, and maintains employee training records

Generates training and compliance reports

Monitors and documents the employee Qualification program, including measures for ensuring employees are trained and can perform the required tasks of a position

Schedules and deliver classroom GMP training and measure effectiveness of learning

Manage the controlled document Library in EDMS and other quality systems, ensuring documents required as a part of GMP are prepared, authorised, and rigorously controlled

Conducts training needs analysis when required (i.e new hire, role change, delivery effectiveness)

Other duties as required

The Candidate

Diploma / bachelor’s degree preferable in a related field

Adult learning techniques an asset

Minimum 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

Ability to sit and use hands and fingers, to handle or feel and to manipulate keys on a keyboard

Use of manual dexterity is required

Ability 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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 due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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