Quality Assurance Compliance Specialist (Quality Systems)

Company Details

Septodont is a leading manufacturer of dental pharmaceuticals and medical devices. The French-based company employs over 2,000+ people globally. We have six manufacturing plants in France, India, North and South America, and an international distribution network that is dedicated to serving the needs of dental professionals in more than 150 countries. Our North American operations have facilities in Ontario, Montreal, and Pennsylvania. It also has Latin American operations with facilities in Brazil and Colombia.

Our Cambridge, Ontario site is also home to our Novocol Pharma division, which focuses on contract development and manufacturing, specialized in sterile injectable cartridge and combination product manufacturing.

Our employees are our number one asset! We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

Job Summary

The Quality Assurance Compliance Specialist is accountable to the QA Manager (Systems) for all activities. There are two (2) focus areas associated with the QA Compliance Specialist role, supplier management and quality systems. Each of the focus areas has specific responsibilities noted in the relevant subsections below. General responsibilities common to each role are also included.

• For internal applications: The deadline to apply is 4pm on August 11. This is a Level 10 role. **

Responsibilities

Supplier Management

• Coordinates and participates in the supplier qualification and external auditing program and ensure that supplier qualification status is reviewed and maintained as required. External auditing includes the requirement to travel to locations across North America, Europe, and Asia at minimum
• Acts as the primary investigator for all internal supplier investigations and supplier complaints, liaising directly with manufacturers and service providers as required
• Maintains the approved supplier list and act as the primary contact for supplier change notifications

Quality Systems

• Provides guidance and support to departmental representatives during the initiation and approval process of change controls
• Provides guidance and support to departmental representatives during the investigation of CAPAs
• Ensures change controls are compliant with regulatory and internal expectations and ensure they are completed and closed within a timely manner and within established timelines
• Oversight and maintenance of the CAPA program
• Ensures CAPAs are compliant with regulatory and internal expectations, and are completed and closed within a timely manner and within established timelines
• Oversight and maintenance of additional quality management systems may be assigned as determined by the QA Manager
• Completion of annual product reviews by performing regular analysis and trending of quality system data to ensure a timely publication of the reports
• Oversight and maintenance of the change control program

General Responsibilities

• Supports activities in Quality Assurance which may include participation as an active member of validation activities, reviews and approves GMP Master Documentation, participates in the internal auditing program, external auditing program, employee training, or incident investigation
• Models the Company Mission, Vision and Values Statements, policies, and
• Provides support for Quality Assurance activities related to both (a) manufacturing operations (e.g., supplier evaluation, CAPA program and facility improvement initiatives) and (b) the release of finished products (e.g., batch record review, deviation investigations and complaint investigations)
• Observes and supports all safety guidelines and regulations
• Investigates and resolves, individually or as an inter-departmental team leader or team member, events, issues, and systems through which quality improvement can be identified, recommended, implemented, and consistently managed
• Follows GMP and regulatory requirements and ensures Quality standards are met
• Act as a Quality lead for internal initiatives designed to enhance Novocol’s overall compliance status (e.g., global harmonization, root cause analysis teams).
• Leads quality projects and initiatives as required that support ongoing GMP compliance at Novocol
• In the absence of the QA Manager act with full authority and decision-making capacity for all QA decisions if designated

Qualifications

Education

• University degree in a related science such as Chemistry, Microbiology, or Engineering

Experience

• Proven ability to work independently with minimal supervision
• Detail-oriented
• Excellent verbal and written communication skills
• 3 years of practical experience in a Quality function or in a leadership role within an Operations group
• Internal and/or external auditing experience (focus: Supplier Management)
• Demonstrated leadership skills with the ability to coach and train others
• Demonstrated ability to problem-solve and make decisions
• Ability to work independently with minimal supervision
• Ability to conduct and lead quality investigations or projects as part of a cross-functional team

Contract type

Permanent