Manufacturing Compliance Specialist

At Septodont, a global leader in dental products and a key player in pharmaceutical development and contract manufacturing (CDMO), we are proud to work every day to improve patients’ health and well-being.

Present in more than 110 countries, the Group relies on the energy, expertise, and passion of 2,600 employees. With 6 international production sites, Septodont combines industrial excellence, technological expertise, and innovation to meet the needs of healthcare professionals worldwide.

In North America, our operations include facilities in Ontario, Quebec, and Pennsylvania. Our Cambridge, Ontario site is home to Novocol Pharma – a thriving center of innovation with over 40 years of expertise in sterile injectable cartridges and combination product manufacturing. Backed by a team of more than 675 dedicated professionals and modern facilities, we deliver high-quality, customer-focused solutions to partners around the world.

Beyond our expertise, our people are our greatest strength. We foster a stimulating work environment where everyone can learn, grow, and build a career that reflects their aspirations, supported by continuous training and internal mobility. As a socially responsible company, we place diversity and inclusion at the heart of our development, convinced that they enhance collective performance and foster human experience.

Joining Septodont means becoming part of a human-scale international group and contributing to a meaningful mission: improving health for as many people as possible. What if your next professional chapter started with us?

We have an opportunity for a Manufacturing Compliance Specialist.

Location: Cambridge, ON (On-site)

Employment Type: Contract (18-months)

Schedule: Monday - Friday, 8:30 am - 4:30 pm

FUNCTION SUMMARY:

The Manufacturing Compliance Specialist is responsible for ensuring root-cause analysis is conducted on investigations for Septodont Operations in Cambridge in a timely and efficient manner. He/she will act as a production quality and technical resource/liaison while preparing, compiling and writing investigation reports for completeness, accuracy, and compliance. He/she will also ensure that established procedures are followed for all investigations and that corrective and preventative actions are implemented.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Conducts investigations for deviations following existing procedures.
• Identifies and/or recognizes critical path for investigations leading to timely identification of root cause, corrective & preventative actions.
• Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion.
• Works to facilitate, coordinate and investigate deviations with the relevant team and Subject Matter Experts (SME) to identify issues and root cause. Utilizes problem solving and root-cause analysis tools to facilitate the investigation.
• Provides on-floor support, when possible, to assist the team with problem solving and help identify the root cause of issues.
• Ensure investigations related to Operations are initiated and written as per existing procedure
• Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. Writes and reviews investigation reports for completeness and accuracy prior to approval by Department Manager.
• Conducts impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (QA, RA, Validation, Production, etc.) and prepare recommendations for Department Managers.
• Prepare and maintain lists, including status and next steps of open investigations for Cambridge Management.
• Review on-going progress on relevant open investigations with Production Management to ensure alignment.
• Facilitates the weekly deviation huddle and supports the team in achieving established key performance indicators (KPIs).
• Project manages the corrective and preventative actions and assists in both implementation and follow-up.

BASIC REQUIREMENTS:

Education

• University Degree in a related science.

Experience

• A minimum of 3 years’ experience in the pharmaceutical industry, Quality Engineering or QA/QC.
• Fluency in project management &, Root Cause Analysis and Corrective Action Tools.
• Superb technical writing skills and abilities.
• Facilitating cross functional teams.
• Superior organizational, interpersonal communication skills.
• Ability to manage time effectively.
• Ability to work independently and manage multiple priorities in a fast-paced and changing environment.
• Good command of the English language, both written and verbal.
• Critical thinking skills with ability to problem solve.
• Knowledge of GMP.
• Proficiency with Word, Excel, and ERP systems.

Compensation

Starting at approximately $76,000.00 CAD, with opportunity for increase based on qualifications and experience. Total rewards include comprehensive benefits and continuous learning and development programs available through our online Learning Management System.

What We Offer

• Excellent compensation and benefits package
• Discounted gym memberships
• Programs supporting work-life balance (EAP)
• Corporate discounts and perks
• Employee recognition program
• Social events and spirit days
• Paid time off
• Ongoing learning and development opportunities

Work Authorization: Applicants must be legally authorized to work in the country where the position is based for the duration of employment. This position is not eligible for employer-sponsored immigration support.

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.