Quality Assurance Coordinator I

General information

Reference

Position description

Category

Quality / HSE - Quality Assurance

Job Title

Quality Assurance Coordinator I

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 Coordinator I.

Job Summary

The Quality Assurance (QA) Coordinator I is accountable to the QA Compliance Supervisor for all activities relating to the preparation of all master documents, coordination of documentation services through other departments, maintenance of systems for control and distribution of all master documents according to Quality and internal requirements, maintaining filing systems for control and security of all master documents as well as archiving records.

Responsibilities

• Prepares and distributes all Quality Master Documents.
• Coordinates the update, routing, and proper completion of Quality documents through other departments.
• Ensures that all documents in Ennov are maintained, administered accurately, and remain current.
• Provides support for Pharma documentation as required.
• Configuration and administration of Ennov training modules.
• Cancels, archives, and reassigns Ennov processes as required.
• Provides training on Ennov and documentation practices to employees.
• Updates Ennov doc units in accordance with the Ennov-Doc Unit Admin policy.
• Prepares training reports via Ennov.
• Supports regulatory and customer audits as required.
• Follows the policy for sharing documents with outside customers.
• Maintains filing systems for control, security, and access of all master documents.
• Archives completed documents and records in accordance with the Record Retention policy
• Reviews contents of batch records at the time of archival in accordance with the Filing, Archival and Requests for Quality Documents procedure.
• Coordinates the pick-up and drop off for archived records through the Shipping department and off-site storage facility.
• Populates the off-site storage facility system with archived records in accordance with the Record Retention policy.
• Records documents signed out to requestors via the record tracking system.
• Ensures QA office supplies are stocked and prepares purchase orders.
• Scans batch records for customers as required.
• Follows Quality and regulatory requirements and ensures quality standards are met.
• Observes and supports 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

Education

• College Diploma in a scientific or administrative function.

Experience

• One (1) year experience in an administrative function.
• Advanced computer skills, specifically in Microsoft Word.
• Records management training would be an asset.
• Excellent organizational skill with strong attention to detail.
• Proficient communication skills, both written and verbal.

Contract type

Permanent

Candidate criteria

Minimum level of education required

2- College

Minimum level of experience required

Less than 2 years

Position location

Job location

North America, Canada, Cambridge

Location

25 Wolseley Court N1R 6X3 Cambridge