Documentation Control Administrator

Job Responsibility:

Document Control Administrator

Position Summary

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 position is located in Windsor, Ontario, one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full-service turnkey solutions.

Reporting to the Compliance Manager, the Document Control Administrator will be responsible for the maintenance and organization of Company documents. The Document Control Administrator will oversee all aspects of generating, changing, filing, archiving and retrieval of documents pertaining to the Company's policies, procedures, specifications, master manufacturing records, instructional materials as well as any other stored records as required.

Regular working hours: Monday - Friday; 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch

The Role:

• Create and revise Standard operating procedures, soft gel specification sheets, and controlled forms as required by approved change requests. Maintains revision records for changes and completes within required time frame.

• Creates and revises Master Batch Production Record documents for commercial products. Maintains revision records for changes to products. Logs, obtains approvals, and tracks progress on master document related change requests.

• Manages requests for the retrieval of documents from off-site storage.

• Assists in maintaining Master Batch Production Record packages and revising Final Packaging documents and specifications, as required and ensures all are up to date and ready according to planning schedule.

• Keeps appropriate records archived for required retention time.

• Prepares manufacturing Record of Product Development and issue approved Authorized Technical Specifications, obtains approvals and issues to production and maintains appropriate storage.

• Acts as the administrator of the change control program, initiating and tracking change controls. Logs, obtains approvals, and tracks progress to closure on related change requests.

• Other duties as assigned.

The Candidate:

• College Diploma required. (Preferably in Business Administration)

• 1+ years of experience in information/document management or related field is preferred.

• Experience working in a manufacturing, pharmaceutical and/or GMP facility is considered an asset.

• Excellent computer skills including Microsoft Office Suite (Outlook, Excel, Access, Word).

• Accuracy and attention to detail while working under tight deadlines.

• Effective communication skills with individuals at all levels of the organization.

• Resourceful, innovative, and able to work independently.

• Flexibility to shift priorities quickly and effectively manages simultaneous requirements.

• 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 occasionally 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.

• 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 View email address on ca.edajobs.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.