Microbiologist, QS7-GQC-MPTLS R

Job Summary

Under the direction of Laboratory Supervisors, the Microbiologist QS7 will conduct and provide Technical Support for Microbiological testing on Finished Products (commercial, R&D development and stability) and Raw Materials, Bacterial Endotoxin Testing and Antimicrobial Effectiveness Testing within the Apotex group of companies.    Other Microbiological Laboratory related duties such as Water testing, identification of bacterial isolates and media Growth Promotion will also be conducted as required.

The Microbiologist QS7 is responsible for ensuring that accurate results are generated and analysts follow GMP requirements in accordance with established compendial and in-house methods. 

The Microbiologist QS7 will act as a Qualified Trainer for the Microbiology department and will be responsible for providing front line support for technical and troubleshooting with regards to investigations, methodology and instrumentation.

In addition, as a senior microbiologist, the incumbent will coach, mentor and assist in the technical development of microbiologists.  

Job Responsibilities

Displays strong technical skills and proficiency in Microbiological Testing of Non-Sterile Products, Sterility Testing, Bacterial Endotoxin Testing and other Pharmaceutical Microbiology Lab related activities.

Directs and leads projects in support of the microbiology department.

Designs and drafts protocols recommending appropriate course of action. Executes or oversees the execution of protocols.

Initiates, leads and facilitates continuous improvement projects for department and collaborates/liaises with department Managers, key customers, suppliers and employees in the identification, prioritization, selection and execution of projects to achieve compliance and deliver business results.

Department’s “go to” person for writing and overseeing execution of special projects

Serves as technical resource within the microbiology team.

Offers assistance to team members with more complex microbiological analysis.

Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

Possesses a sound understanding of microbiology, compendial/regulatory requirements  

Provides technical explanations and advice on regulatory and cGMP requirements for various microbiological processes   

Serves as primary technical support in microbiological troubleshooting with regards to methodology and instrumentation including LIMS.

Assists laboratory management in the development of all levels of microbiologists.

Acts as qualified trainer for microbiology department with ability to effectively train staff individually or in a group setting.    

Coaches/mentors and assists in the technical development of microbiologists

Provides technical guidance to laboratory staff on a daily basis.

With a keen eye for detail, reviews work for accuracy and alignment with procedures.

Prepares documentation and reviews test results for OSD products tested by 3rd party labs

Excellent verbal and written communication skills; clear and concise technical writer.

Supports leadership teams in preparation of trend reports and metric development and reporting in order to monitor compliance and efficiency. Proactively measures and analyzes trends to support and drive positive change

Initiates and conducts Out of Specification (OOS), Out of Trend (OOS) or other lab or facility investigations (QMS & LIR)

Acts as a designate to the Supervisor assisting with scheduling, prioritizing tasks and laboratory investigations.

Directly involved in on site customer and regulatory audits, acting as a front line subject matter expert during audits/inspections and through data support. Responsible for self-audit activities for department.

Coordinates and monitors the availability of laboratory supplies and equipment.

Strong knowledge of regulatory requirements and standards (FDA, EU, ICH, ISO, USP). Keeps abreast with changing microbial expectations.

Develops reviews and revises laboratory methods and Standard Operating Procedures. Works within cross-functional teams; communicates progress effectively to other team members.

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.

Performs other duties as assigned

Job Requirements

• Education
  • Sc. in Microbiology, or similar qualification in a closely related field.

• Knowledge, Skills and Abilities

• Computer skills; good understanding of LIMS would be an advantage.
• Good knowledge and working experience with a wide range of microbiological techniques
• Able to interpret results and perform work with minimal supervision.
• Good leadership and interpersonal skills with demonstrated ability to coach staff and to discuss technical issues.
• Supports the promotion of a positive, inclusive work environment; motivating peers.
• Detail oriented with excellent problem solving skills.
• Strong understanding and utilization of compendia, regulatory requirements and Good Laboratory Practices.
• Proven organizational and time management skills, as demonstrated through previous work and/or educational experience.
• Job may require repetitive, routine bench-work including activities such as pipetting, serial dilutions and sub-culturing.  
• Job may involve shift rotations, Evening or Night shift with weekend coverage as required

Experience

• >3 years’ experience in Pharmaceutical Microbiology Laboratory.