Lead engineer Jobs in Vaughan, ON

Overview

Microbiology Lead role at Apotex Inc.

Apotex is a Canadian-based global health company that provides affordable medicines and health products worldwide. Headquartered in Toronto with regional offices globally.

For more information visit : www.apotex.com.

Job Summary

Responsible for generating accurate results while following GMP requirements. Responsible for conducting analysis and providing technical support for microbiological testing on products (Commercial, R&D development and Stability), including Bacterial Endotoxin Testing, Sterility Testing, Environmental Monitoring, Antimicrobial Effectiveness Testing and Bacterial Identification, in accordance with established compendial and in-house testing methods, while working under minimal supervision. This role, as Microbiologist Lead, QS8, includes coaching, mentoring and assisting in the technical development of junior Microbiologists and providing support and troubleshooting expertise in microbiological analysis as required.

In a leadership capacity, the Microbiologist Lead oversees a team responsible for initiating, tracking and facilitating timely closure of Change Controls. The Lead also reviews and approves documentation for the Microbiology department, completes special test requests, and executes compliance and process improvement projects in line with SOPs, GMP and GLP. The role acts as a Qualified Trainer for the Microbiology department and provides front-line support for investigations, methodology and instrumentation. Responsibilities include supervising laboratory personnel and approving water, raw materials and finished products in accordance with internal and regulatory requirements.

Job Responsibilities

• Display strong technical skills in microbiological testing of non-sterile products, bacterial endotoxin testing, sterility testing, environmental monitoring, antimicrobial effectiveness testing, bacterial identification and related activities. Provide support in the operation of instrumentation and equipment.
• Initiate, direct and lead projects in support of the microbiology department. Design and draft protocols, recommend action, and oversee protocol execution.
• Collaborate with department managers, key customers, suppliers and employees to identify, prioritize, select and execute projects.
• Recognize OOS or Out of Trend results and complete laboratory investigations. Interpret and document test results, calculations and observations; prepare comprehensive reports and assist leadership with trend reports and metrics.
• Troubleshoot complex products as a technical resource within the microbiology team. Provide coaching and training to other microbiologists as appropriate and assist in development at all levels.
• Act as primary qualified trainer for the microbiology department and assist management in qualifying new microbiologists for proficiency testing.
• Coach and mentor microbiologists; support Change Controls as required. Prepare weekly schedules and task assignments to support manufacturing activities, ensuring deadlines are met with minimal supervision.
• Ensure proper disposal of biological waste and order media or laboratory supplies as required.
• Perform roles of document reviewer, review raw material and finished product data for conformity to specifications and regulatory requirements. Prepare documentation for shipment of products tested by third-party labs; review third-party results and supplier COA when required.
• In supervisor absence, schedule work for junior staff and issue lab investigations, VIC reports and QMS deviation investigations as needed. Support on-site customer and regulatory audits as a frontline subject-matter expert during audits and data support.
• Maintain compliance with GMP, GLP and regulatory requirements. Uphold Ontario occupational health and safety and related biosafety guidelines and Apotex health and safety policies. Perform other duties as assigned.

Job Requirements

At Apotex, we are committed to fostering a welcoming and accessible work environment where everyone feels valued, respected, and supported to succeed. We offer accommodations for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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