Laboratory Compliance Coordinator

Laboratory Compliance Coordinator

Windsor, Ontario is 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.

Position Summary

Reporting to the Laboratory Compliance Manager, the Laboratory Compliance Coordinator is accountable for ensuring the accuracy of raw material, finished product and stability testing by auditing all laboratory workbook calculations and values. They are responsible for collecting finished product samples, logging all samples into the laboratories, and coordinating all samples and documentation. The incumbent will also be responsible for raw material label preparation, general administration of the laboratories and maintaining a GMP level in the laboratories that comply with regulations.

The Role

• Auditing of analytical workbooks. Handle all laboratory documentation

• Review analytical data and coordinate investigations into out of trend conditions. Record data as required by GMP (Good Manufacturing Practices)

• Ensure that excellent documentations, Controls and capabilities are in place to maintain data integrity

• Identify laboratory data integrity risks and support the proposed improvement plans.

• Perform the internal laboratory compliance monitoring program

• General Laboratory Administration duties including compilation and filing of reports, collecting sampling and logging samples to the laboratories and correspondence and arrangement of outside testing, as required.

• Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met

• Perform other duties as required

The Candidate

• Bachelor’s Degree in Science, Chemistry or related field required

• 3+ years of experience in an analytical laboratory

• Experience working in a pharmaceutical and/or GMP facility

• Knowledge of laboratory techniques, terminology, equipment, and materials

• Knowledge of the principles and practices of chemical, biological and physical testing and analysis including the preparation of materials, equipment, and samples

• Demonstrate applicable ethics and due diligence

• Soong interpersonal skills in dealing with people at all levels and in a variety of functions; able to influence and motivate others to quickly achieve results

• Knowledge of automation systems an asset

• Demonstrated ability to work independently, take initiative and complete assigned projects independently

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

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

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 incl. vacation, banked time & personal time.

• Employee Reward & Recognition programs.

• Opportunities for professional and personal development & growth incl. 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.