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Quality Assurance Compliance Specialist

3 months ago

Cambridge, Canada Septodont Full time

**General information**:
**Reference **:2023-1444

**Position description**:
**Job Title**:
Quality Assurance Compliance Specialist (Suppliers)

**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**:
Reporting to the Senior QA Manager (Systems), the Quality Assurance Compliance Specialist focuses on all activities related to supplier management and quality systems. Each of these focus areas has specific responsibilities noted in the relevant subsections below. General responsibilities common to each role are also included.

**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 travel to locations across North America, Europe, and Asia at a minimum
- Maintains the approved supplier list and acts as the primary contact for supplier change notifications
- Acts as the primary investigator for all internal supplier investigations and supplier complaints, liaising directly with manufacturers and service providers as required
- Reviews and updates Quality Agreements with suppliers
- Facilitates completing the agreements in a timely manner

**General Responsibilities**
- Leads quality projects and initiatives as required that support ongoing GMP compliance at Novocol
- 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)
- Acts as a quality lead for internal initiatives designed to enhance Novocol’s overall compliance status (e.g. global harmonization, root cause analysis teams)
- In the absence of the QA Manager, acts with full authority and decision-making capacity for all QA decisions if designated
- 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
- 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
- Follows GMP and regulatory requirements, and ensures quality standards are met
- Observes and supports all safety guidelines and regulations
- Models the company mission, vision and values statements, policies, and current standard business practices
- Performs other related duties as required

**Qualifications**:
**Education**
- University degree in a related science such as Chemistry, Microbiology, or Engineering

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

**Contract type**:
Permanent

**Minimum level of education required**:
3- Bachelor

**Minimum level of experience required**:
2-5 years

**Languages**:
English (3- Advanced)

**Position location**:
**Job location**:
North America, Canada, Cambridge

**Location**:
25 Wolseley Court