Laboratory Compliance Coordinator (Contract)

Catalent Pharma Solutions; Ontario; On-site; CAD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Laboratory Compliance Coordinator to ensure the accuracy of laboratory testing and maintain compliance with regulations. This role involves auditing analytical workbooks, coordinating sample documentation, and supporting a culture of quality and safety. Join a dynamic team dedicated to delivering life-enhancing products and experience professional growth in a collaborative environment. If you are detail-oriented and passionate about laboratory compliance, this opportunity will allow you to make a meaningful impact in the pharmaceutical industry.

Benefits

Opportunities for professional development

Employee Resource Groups focusing on D&I

Qualifications

• 3+ years of experience in an analytical laboratory is preferred.
• Knowledge of laboratory techniques and GMP principles is essential.

Responsibilities

• Auditing analytical workbooks and handling laboratory documentation.
• Coordinating investigations into out of trend conditions.

Skills

Analytical Skills

Interpersonal Skills

Initiative

Attention to Detail

Knowledge of GMP

Education

Bachelor's Degree in Science

Tools

Microsoft Office Suite

Job description

Laboratory Compliance Coordinator

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This position is located in Strathroy, 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 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 Laboratory Compliance Coordinator 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.

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

- 12 month contract

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.

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.

• Other duties as assigned.

The Candidate

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

• 3+ years of experience in an analytical laboratory is an asset.

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

• Currently Catalent does not participate in the Ontario Immigrant Nominee Program (OINP).

• 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.

• 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.

• Strong 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 is 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).

• 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.

• There is also the potential exposure to chemicals.

Why You Should Join Catalent:

• Opportunities for professional and personal development & growth.

• Several Employee Resource Groups focusing on D&I.

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 [e-mail]. 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.