Job Description

Company detail

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 Microbiologist I.

Job Summary

The Microbiologist I is an entry-level position accountable to the Microbiology Supervisor and is responsible for microbiological testing to support the production facility.

Responsibilities

• Performs testing including, but not limited to the following:
  • Environmental monitoring of air and surfaces in the Aseptic Processing Area, including viable and non-viable testing methodology.
  • Personnel monitoring of all employees qualified for entry into the Aseptic Processing Area.
  • Sterility testing of finished goods.
  • Bioburden testing of WFI and other water systems, and raw materials and components as required
  • Pyrogen testing of finished goods.
  • Read plates and report the results of microbial tests.
  • Bacterial identification/speciation of isolates selected from the monitoring results.
  • Preparation and purchasing of microbiological media (both purchased products and those manufactured in-house).
  • Preparation, sterilization and sanitization of equipment and facilities used in the conduct of microbial testing, including the sterility-testing suite.
• Must pass initial gowning certification requirement and must maintain monthly and yearly gowning certification.
• Supports in-process Quality Control monitoring and trending in production areas.
• May support the, DIR and OOS investigations and developing/updating SOP’s and reports.
• Acts as a subject matter expert and provide gown training for production staff.
• Participates in internal and external audits as required.
• Follows GMP 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.
• Performs other duties as required.

Qualifications

Education

• Diploma or a University degree in a related science (Microbiology).

Experience

• 2 years’ of related experience in Microbiology or related field.
• Proven analytical and problem solving skills.
• Demonstrated organizational skills with the ability manage multiple priorities with minimal direction.
• Effective communication skills both verbal and written.
• Experience working in a self-directed team environment is essential.

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