Document Control Administrator
Position Summary
Work Schedule: Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.
This position is 100% on-site at the Windsor or Strathroy site
This position can be located in Windsor, Ontario or Strathroy, Ontario, our 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 Associate Director, Compliance, 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.
The Role:
Creates and revises SOPs and controlled forms (ACF/REF) as required by approved change requests. Maintains revision records for changes and completes within required time frame.
Creates and revises Master Batch Production Record (MBPR) documents for commercial products based on approved requests. Maintains revision records for changes to products.
Creates product and raw material analytical report and certificate of analysis templates.
Assists in maintaining MBPR packages and ensures all are up to date and ready according to planning schedule. Keeps appropriate records archived for required retention time.
Provides support and assumes delegated responsibilities for compliance-related programs and initiatives as assigned by the Director.
Achieves Required Results in productivity, quality and services as defined through key performance indicators for the department
Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met
Performs other duties as required
The Candidate:
High School Diploma, GED/CAEC and/or educational credential assessment (ECA) is required, College Diploma and/or bachelor’s degree in business administration or related field preferred.
1+ years of experience in information/document management or related field is preferred. Experience working in a manufacturing, pharmaceutical and/or GMP facility 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
This position does not qualify for sponsorship.
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 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.
Pay:
The final salary offered to a successful candidate may vary within this range $47,000 - $60,000, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a global employer, and this salary range does not reflect positions that work in other countries.
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.
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.
catalent