Quality Assurance Auditor

Novocol Pharma, a Septodont company; Cambridge; On-site; CAD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Assurance Auditor to join their team. This role involves ensuring compliance with GMP standards through routine audits and quality assessments. You will provide invaluable support to manufacturing activities and participate in continuous quality improvements. The company values its employees and offers excellent compensation, developmental opportunities, and a supportive work-life balance. If you are detail-oriented and passionate about quality assurance in the pharmaceutical industry, this is an exciting opportunity to make a significant impact.

Benefits

Excellent compensation/benefits package

Bonus and reward programs

Discounted gym memberships

Work-life balance programs

Employee recognition program

Professional development programs

Social events and spirit days

Qualifications

• 2+ years experience in GMP/cGMP environment required.
• Strong communication and problem-solving skills are essential.

Responsibilities

• Conduct routine audits to ensure compliance with quality standards.
• Provide GMP training and support internal audit programs.
• Assist in investigations and root cause analysis.

Skills

GMP Compliance

Auditing Skills

Problem-Solving

Communication Skills

Detail-Oriented

Education

Bachelor of Science Degree in a related life science

Job description

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 role involves providing feedback on overall operations compliance to procedures and GMP, supporting manufacturing activities, and participating in quality assessments and improvements through routine monitoring and auditing of product quality and process performance.

Responsibilities

PRIMARY DUTIES AND RESPONSIBILITIES:

1. Conduct routine process, product, and AQL audits to monitor process performance and compliance with SOPs and quality standards.
2. Perform documentation audits of manufacturing documents, logbooks, and related documents.
3. Participate in the internal audit program, supporting GMP compliance.
4. Assess damaged products to determine their status.
5. Maintain and review visual inspection qualification status and documentation.
6. Support aseptic media fill visual inspection qualification, process, and product reconciliation.
7. Oversee rework operations, ensuring procedures are followed and documented.
8. Review records for release to inspection and perform identity verification on packaged batches.
9. Provide GMP training to departments as needed.
10. Maintain and monitor the retain room, perform physical examinations of finished products, especially during shelf life or product complaints.
11. Assist in investigations and deviations.
12. Support evaluation of incidents and deviations, participate in root cause analysis, and help identify corrective actions.
13. Participate in technical studies for new components, products, and R&D projects.
14. Participate in supplier audits and file reviews.
15. Provide feedback on corrective/preventive actions, new processes, equipment, and change controls. Assist in closing DIRs/CCRs during off-shifts.
16. Adhere to GMP and regulatory requirements, ensuring quality standards are met.
17. Observe safety guidelines and regulations.
18. Demonstrate company mission, vision, values, policies, and standard practices.
19. Perform other duties as required.

Qualifications

BASIC REQUIREMENTS:

• 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 minimal 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. Only shortlisted candidates will be contacted. We follow Ontario Human Rights Code and Accessibility for Ontarians with Disabilities Act for an inclusive recruitment process. Beware of recruitment fraud; official communication will be through our careers site and official email addresses.

Internal Job Posting Grade 8. Application deadline for internal applicants is May 13, 2025.

Contract Duration: 8 months

Shift: Night Shift, Sunday to Thursday, 10pm - 6am

Contract type

Contract