Documentation & Training Specialist

Documentation and Training Specialist

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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. 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.

Reporting to the Quality Assurance Supervisor, 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..

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

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 / 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.

• Strong communication skills, the candidate should be able to create engaging training materials, deliver presentations, and facilitate group discussions.

• Ability to manage multiple activities simultaneously, including planning, organizing, and coordinating resources.

• Proficiency with learning management systems (LMS), Electronic Documentation Management Systems (EDMS) e-learning software, and other technologies is important.

• Experience in conducting training needs assessments and measuring the impact of training programs is valuable.

• Strong interpersonal skills are crucial to collaborate with various stakeholders, including subject matter experts, trainers, and employees at different levels of the organization.

• Expertise in contemporary tools to meet current and advancing cGMP requirements.

• 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. 

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 DisabilityAccommodations@catalent.com. 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.

APPLY