Microbiology Specialist (Day Shift)
Bimeda View all jobs
- Cambridge, ON
- $65,000-85,000 per year
- Permanent
- Full-time
Location: Cambridge, ON (In-Office)
Position Type: Full-time regularShift: Day Shift, Monday - Friday (5:00AM - 1:30PM)
Vacancy Status: This role is currently vacant
AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicantsJob Summary:Reporting to the Microbiology Supervisor, the Microbiology Specialist 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.Key Role Specific Requirements:
- 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.
- Specialize in the Aseptic manufacturing environmental monitoring and various microbial testing and provides training and feedback to the Microbiologists and the Aseptic department as required.
- Specialize in various microbial testing such as Sterility test, BET, Bioburden, GPT, Microbial Assays and Identification.
- Assists 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 Supervisor any corrective actions that need to be taken in response to excursions in controlled environmental conditions and makes recommendations.
- Participates in technical studies for research and development projects. Supports development of validation protocols and preparation of related reports.
- Assists validation in coordination of activities for media fills.
- Revises laboratory Standard Operating Procedures and test methods 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.
- 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 specialist qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
- Effective communication skills.
- Competitive salary.
- 13 paid holidays.
- Competitive vacation policy effective upon hire.
- 5 paid personal care days.
- Employee Assistance Program.
- Expected Salary Range: $65k - $85k/Year
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs. We are committed to an inclusive and accessible recruitment process. We are an equal-opportunity employer and assess candidates based on skills and experience. Recruitment records are retained in accordance with Ontario law.