Microbiologist, QC EnviMonQS5-GQC-QCEM R
Date: Nov 6, 2024
Location: Richmond Hill, ON, CA, L4C 5H2
Company: Apotex
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com.
Job Summary
Under the direction of Laboratory Supervisor or co-ordinator, the Microbiologist will conduct various Environmental monitoring activities of utilities and premises within the Apotex group of companies. Other Microbiological Laboratory related duties such as processing of Environmental monitoring samples will also be conducted as required.
The Microbiologist, is responsible for generating accurate results while following GMP requirements in accordance with established compendial and in-house procedures.
Job Responsibilities
- Displays an understanding of and proficiency in Environmental monitoring and other Pharmaceutical Microbiology Lab related activities.
- Good understanding of compendial requirements pertaining to microbiological test activities. Works collaboratively with microbiologists, co-ordinator and the supervisor in troubleshooting obstacles.
- Demonstrates a good working knowledge of LIMS and SAP and as required.
- Assists in the execution of protocols and preparation of trend reports.
- Ensures sampling is conducted in a timely manner to meet required turn-around times.
- Accountable to maintain compliance with assigned training plan pertinent to job functions.
- With a keen eye for detail, performs verification of microbial test results and calculations generated by peers. Review work for accuracy and alignment with procedures.
- Ensures timely communication of any out of specification and out of trend investigations to management and co-ordinator.
- Escalate any safety related issue to management in a timely manner.
- Ensures issues regarding methodology and instrumentation are communicated to Leadership.
- Coordinates and monitor inventory for Environmental monitoring supplies and equipment.
- Promotes a positive work environment and be a good team player.
- Ensures that all work is performed in compliance with current Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Procedures, established safety standards, compendial and other regulatory requirements.
- Performs all work in support of our Corporate Values.
- All other duties as assigned
Job Requirements
- Education
- Minimum Diploma in Microbiology or similar qualification in closely related field
- Knowledge, Skills and Abilities
- Good knowledge of microbiological techniques including aseptic technique
- Good Computer skills; prior experience with LIMS would be an advantage.
- Able to interpret results and perform work with minimal supervision.
- Good verbal and written communication and interpersonal skills.
- Detail oriented with excellent problem solving skills.
- Strong understanding and utilization of GMP and GLP.
- Proven organizational and time management skills, as demonstrated through previous work and/or experience.
- Job will require repetitive, routine Environmental monitoring activities. In addition, job will require work inside a manufacturing area or mechanical room for sample collection.
- Job will involve shift rotations, Evening or Night shift with weekend coverage or working at different site as required.
- Experience
- Prior experience in Pharmaceutical Industry preferred.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation 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.