General information
Position description
Category
Operations - Manufacturing
Job Title
Batch Record Reviewer (CONTRACT)
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 CONTRACT BATCH RECORD REVIEWER.
Shift Hours: 4:00PM - 12:00AM
Job Summary
The Batch Record Reviewer is accountable to the Production Manager for all activities relating to Manufacturing Documents. This will be performed in accordance with the requirements outlined in Standard Operating Procedures and Good Manufacturers Practices.
Responsibilities
* Performs documentation reviews for records of departmental and related activity in compliance with
*GMP and company procedures.
* Completes and/or reviews documentation entries in the batch record.
* Performs document tracking and routing
* Communicates the requirements for related batch release activities to Production on a daily basis.
* Follows GMP and regulatory requirements and ensures quality standards are met.
* Must follow safety rules/regulations and report any workplace injuries to supervisor immediately.
* Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.
*Works harmoniously with all fellow employees.
* Performs other related duties as required.
Qualifications
Education
* High School completion.
Experience
* Experience in Quality Assurance, Sterile Manufacturing is preferred.
* Strong attention to detail.
* Mathematical ability with strong attention to detail and accuracy.
* Ability to work in a fast paced environment.
* Team oriented.
Contract type
Contract
Position location
Job location
North America
