Quality Control Microbiologist

Job description

Role Overview

We are looking for a Microbiologist to be responsible for performing microbiological testing, environmental and utility monitoring, and quality control activities in accordance with cGMP, safety, and regulatory requirements. The role supports routine manufacturing operations, product release, validation activities, cleanroom qualification, and overall microbiological compliance across the site.

Key Responsibilities

Perform routine and non-routine microbiological testing, including Sterility, Bacterial Endotoxin, Bioburden and Microbial Limits Testing.
Conduct environmental monitoring of cleanrooms, production areas and laboratories, including particle monitoring.
Perform microbiological monitoring and sampling of utility systems including Purified Water, WFI, Pure Steam, Compressed Air and Nitrogen.
Perform microbial identification of bacteria, mould and yeast from environmental, water and product samples.
Conduct media sterility checks, Growth Promotion Testing and maintenance of microbial cultures.
Support personnel, cleanroom and plant qualification/requalification and validation activities.
Prepare and review microbiology-related documentation including SOPs, protocols and test reports.
Coordinate laboratory equipment calibration, maintenance and validation with vendors and service providers.
Maintain laboratory consumables and coordinate with relevant suppliers.
Work closely with Quality, Operations, Engineering, Projects and other departments to provide microbiological and technical support.
Ensure all activities comply with cGMP, SHE and applicable quality requirements.
Perform other duties as assigned by the Supervisor or Manager.

Qualifications

Bachelor's Degree in Microbiology, Biological Sciences, General Science, Engineering, or a related discipline.

Required Skills & Competencies

Good understanding of cGMP requirements and laboratory safety practices.
Knowledge of microbiological laboratory techniques and aseptic practices.
Good understanding of environmental and utility monitoring within a pharmaceutical or regulated manufacturing environment.
Strong attention to detail and ability to maintain accurate laboratory documentation.
Good written and verbal communication skills.
Ability to work effectively with cross-functional teams, external vendors, and service providers.
Ability to work independently while adhering to established procedures, quality standards, and regulatory requirements.

Required skills

attention to detail quality control engineering validation communication skills operations quality assurance projects cross-functional teams she regulatory requirements compressed air microbiology sops test reports protocols service providers cgmp purified water product release general science environmental monitoring pharmaceutical manufacturing manufacturing operations cleanroom qualification biological sciences external vendors microbiological testing wfi plant qualification laboratory equipment maintenance nitrogen microbial identification laboratory documentation sterility testing pure steam utility monitoring microbiological compliance bacterial endotoxin bioburden testing microbial limits testing particle monitoring media sterility growth promotion testing microbial cultures personnel qualification laboratory equipment calibration laboratory equipment validation laboratory consumables laboratory safety practices aseptic practices regulated manufacturing

Quality Control Microbiologist

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