Microbiologist; Afternoon Shift

Job Title:

Microbiologist

Location:

Cambridge, ON
Position Type:

Full-time Regular

Shift: Afternoon Shift, Monday - Friday, 11:00am- 7:30pm
Vacancy Status:
This role will be vacant in October
AI Disclosure in Hiring:
Artificial intelligence (AI) may be used to assist with certain aspects of the recruitment process, including the initial review and screening of applications. Final hiring decisions are made by Human Resources and hiring managers.

Job Summary

Reporting to the Microbiology Supervisor, the Microbiologist ensures that the Microbiology laboratory provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations in aseptic environmental monitoring and various microbial testing. Acts as backup for the Microbiology Supervisor in their absence.

Job Duties

• Ensures that microbiology testing for raw materials and finished product is completed in a timely and accurate manner to meet product manufacturing requirements for manufacture and release.
• Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and meets housekeeping and cleanliness standards.
• Develops and validates testing methods used in routine analysis of incoming raw materials and finished products.
• Reviews all documentation for accuracy and completeness and ensures that it’s in compliance with current GMPs/GLP, Good Documentation Practices, SOPs and company policies.
• Specialize in the Aseptic manufacturing environmental monitoring and various microbial testing and provides training and feedback to the Microbiologists as required.
• Specialize in various microbial testing such as Sterility test, BET, Bioburden, GPT, Microbial Assays and Identification.
• Assistants as needed in the preparation of investigations relating to deviations in raw materials, finished products and environmental monitoring. Provides technical support in evaluating incidents and interventions during filling operations.
• Communicates to the Manager any corrective actions that need to be taken in response to excursions in controlled environmental conditions and makes recommendations.
• Responsibility includes to develop validation protocols, write related project reports. In addition, update laboratory documentation, SOPs and test methods as required.
• Participates in technical studies for research and development projects, as assigned or scheduled.
• Supports microbiology validations and other projects and offers technical expertise for Microbiology investigations. Assists validation in coordination of activities for media fills.
• Revises laboratory Standard Operating Procedures as required.
• Participates in internal and external audits as required. Acts as a subject matter expert and may assist in providing gown training for production staff.
• Other duties as assigned.
• Might need to stay longer than you schedule shift to meet the business requirement.

What you bring to the role

• 3-5 years of experience in a regulated pharmaceutical industry including Quality Assurance.
• Specializes in Aseptic environment monitoring and various microbial testing.
• BSc degree in Microbiology, Biology or related field.
• Knowledge of Aseptic Environmental monitoring, various microbial testing, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes.
• Must possess apparent microbiologist qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
• Effective communication skills.

Competencies Required for the Role

FOSTERING COLLABORATION/TEAMWORK is the ability to work jointly with others or together especially in an…