Quality Assurance Auditor

2 months ago

Cambridge, Canada Septodont Full time

**General information**:
**Reference **:2024-1886

**Position description**:
**Job Title**:
Quality Assurance Auditor - Contract (15 months)

**Company Details**:
Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridges and combination product manufacturing. We strive for excellence and customer-centricity to deliver value to global pharmaceutical clients through contract services for drug development and commercial manufacturing. With over 40 years in operation, our team of 600 employees and modern facilities, located in Cambridge, Ontario provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality, integrity, and value.

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.

We are a proud member of the Septodont group of companies. Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management. The group counts over 2000+ employees worldwide and has remained a 100% family-owned company for over 90 years. Our Cambridge facility serves as a significant manufacturing site within the Septodont group with high volume dental anesthetic production for a global customer base.

We have an opportunity for a Quality Assurance Auditor.

**Job Summary**:
The Quality Auditor is accountable to the QA Compliance Supervisor. The Quality Auditor will provide feedback on overall operations compliance to procedures and GMP. This role provides quality technical support to manufacturing activities, participates and plays a key role in implementation of quality assessments and improvements through routine monitoring and auditing of the product quality and the process performance.

Employment type - Contract - 15 months.

Shifts type - Nights shifts - Sunday - Friday, 10:00 pm - 6:00 am.

**Responsibilities**:
PRIMARY DUTIES AND RESPONSIBILITIES:

- Conducts routine process, product and AQL audits to monitor overall process performance and compliance with SOP’s, and accepted quality limits and standards.
- Performs documentation audits of manufacturing documents, logbooks and other associated documents.
- Participates in the internal audit program as assigned thus providing support and feedback on GMP compliance.
- Assess damaged product as required to determine product status.
- Maintains and tracks visual inspection qualification status and review the associated documentation.
- Supports aseptic media fill visual inspection qualification, process and product reconciliation.
- Oversees rework operations to ensure that procedures are being followed and clearly documented.
- Reviews completed records for release to inspection. Performs identity after packaging on all batches that are packaged for sale.
- Provides GMP training as required to all departments.
- Maintains and monitors the retain room and performs regular physical examination of the finished product throughout the shelf life, and when warranted due to product complaint investigation.
- Assists as needed in the preparation of investigations and deviations.
- Provides technical support in evaluating incidents and deviations, participating as required in root cause analysis, and identifying corrective and preventive actions.
- Coordinates and participates in technical studies for new components or products and research and development projects, as assigned or scheduled.
- Participates in supplier auditing and file reviews as required.
- Provides feedback as necessary for operations implementation of corrective/preventive actions, new processes or equipment, and change control requests. Assist production in closing DIRs/CCRs during off shifts.
- Follows GMP and regulatory requirements, and ensures quality standards are met
- Observes and support all safety guidelines and regulations.
- Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.
- Performs other related duties as required.

**Qualifications**:
BASIC REQUIREMENTS:
Education

Bachelor of Science Degree in a related life science.

Experience
- Minimum of 2 years practical experience in a GMP/cGMP environment.
- Ability to work independently with mínimal supervision.
- Excellent verbal and written communication skills.
- Strong problem solving and decision-making skills.
- Detail oriented.

What we offer:

- Excellent compensation/benefits package.
- Bonus and reward programs
- Discounted gym memberships
- Programs supporting work life balance
- Employee recognition program
- Professional and personal development programs
- social events and spirit days

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding

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