Quality Control Microbiologist Ii

Position title: QC Microbiologist II
Report to: QC Microbiology Supervisor

Position Summary
As the QC Microbiology Analyst, you will work within the Quality Control Team to respond to Manufacturing microbiological analyses requests. The QC Microbiologist II position includes all analyses routinely completed at the QC Microbiologist I level, as well as additional duties(requests/projects/validation) not routinely performed by all Microbiology Analysts. The additional responsibilities may include performing review of test data (initial review through final disposition and reporting), ordering supplies for the laboratory or serving as a laboratory representative for various project or validation. The QC Microbiologist II can also participate in the investigation process (OOS, investigations, etc). The QC Microbiologist II will act as a leader in the group. The QC Microbiologist II duties will consist of approximately 80% direct testing or testing related to validation/projects and approximately 20% non-direct testing responsibilities (data review, ordering, etc.)

Main responsibilities:
• Perform all microbiology laboratory tasks in accordance with cGMP. • Perform analysis on components, raw materials, products (semi-worked, finished) and utilities to ensure a high level of quality of manufactured products. Follow the standard operating procedures (SOP) and cGMP for the following tests after having been trained and qualified according to the test type:

o Filtration of water/in-process samples for microbial enumeration test
o Sterility test
o Identification of microorganisms o Gram staining, complementary biochemical tests such as but not limited to catalase, oxidase, hemolysis, etc.
o Preparation of culture media (if required)
o Control of the culture media prepared and/or purchased and ready for use
o Incubation of biological indicators and population verification (if required)
o Viral marker test for plasma screening (Nucleic Acid Amplification Test, Enzyme Immunoassay)
o ELISA
o Cell based potency assay
o Detection of bacterial endotoxins (BET)
o Quality control of nitrogen distribution and compressed air (viable/non-viable) utilities
o Environmental monitoring of viable and non-viable particulate matter in classified areas (A, C and D)

• Perform analytical tests for the validation and/or stability of material/products
• Perform the verification and qualification of instruments as required.
• Perform reagent preparation, cleaning of classified area and regular equipment maintenance (incubators, water baths, etc.) as per the SOPs • Immediately communicate all out of specification results (OOS), out of trend results (OOT) or atypical results to the Microbiology Supervisor and participate in laboratory investigations.
• Promptly report any deviation/derogation from the procedures/methods to the Microbiology Supervisor and participate in laboratory investigations.
• The QC Microbiologist II must ensure a high level of conformity of their own training status and review it in a timely manner
• Follow up the inventory of the laboratory material and carry out the orders according to the internal procedures
• Receive and manage samples that enter the laboratory for stability and release testing.
• Complete all required documents legibly and accurately. Maintain good documentary practices at all times when documenting laboratory notebooks, forms, worksheets and training files and all other GMP documents. Ensure the integrity and traceability of generated data.
• Use of a laboratory information management system (LIMS) for data entry of environmental monitoring, consult procedures, initiate and document any investigation related to incidents/deviations and management of change requests.
• Participate in the management of retention and stability samples, as well as samples intended for destruction
• Collaborate with the Microbiology Supervisor to optimize laboratory efficiency, support laboratory coordination and provide any suggestion on the transfer of methods and validation studies of analytical methods.
• Perform any other related tasks deemed relevant in the performance of its duties.
• Write documents related to laboratories activities to comply with GMP and Standard Operating Procedures (SOP).

Qualifications
• A minimum of a bachelor’s degree in microbiology as well as relevant experience in a biotechnology or pharmaceutical laboratory preferably • Experience in a highly controlled and regulated field
• Experience with good manufacturing practices (GMP)
• Practical knowledge of cGMP, QC laboratory environment and equipment associated with the testing of biopharmaceutical products.
• Related experience : 3 to 5 years of professional experience in a Microbiology Laboratory governed by cGMP
• Good knowledge of USP, Ph. EUR. Pharmacopoeia, GMP, Good documentation Practices and Data Integrity requirements
• Experience with LIMS systems is an asset
• Strong skills with MS Office suite (Word and Excel) and Windows environment
• Great sense of organization, attention to detail and ability to meet deadlines
• Able to rigorously apply, monitor and maintain the rules, regulatory requirements, procedures and processes in place.
• Ability to follow written procedures with emphasis on the details.
• Must be able to work autonomously and as a team
• Able to perform multiple tasks in strict deadlines
• Be proactive to help prevent and solve problems
• Excellent oral and written communication skills and good interpersonal relationships
• Fluent both in French and English
• Opportunities to work evening and night shifts (as needed)