The Microbiologist IV is responsible to work independently under the direction of the QC Microbiology leadership performing complex microbiological and physical analyses associated with commercial production, stability samples and environmental/water monitoring samples. As a Microbiologist IV, responsibilities also extend to providing technical and analytical training when necessary along with functional leadership to the QC Microbiology Laboratory.
How you’ll spend your dayPerforms complex microbiological and physical analyses on commercial production and stability samples as well environmental/water monitoring samples in an efficient, safe and compliant (GMP) manner following all applicable Standard Operating Procedures and Analytical Testing Monographs.
Proficient in the use of complex microbiological techniques, such as isolation / identification procedures, preservative challenge testing, and microbiological assay procedures.
Proficient at an expert level in microbial limit analysis.
Assists the functional leader and team members in troubleshooting & resolving analytical problems.
Provides training to team members.
Produces complete, accurate and clear analytical reports.
Responsible for the analytical integrity of all work performed.
Collaborates with the functional leader and laboratory group to prioritize projects and utilize resources to ensure deadlines are met in a safe and compliant manner.
Supports the functional leader in the analytical investigation process ensuring that the following criteria and steps are adhered to as part of the process.
The following criteria are evaluated with each investigation.
Ensures the efficient scheduling and timely completion of work in accordance with the established priorities.
Actively participates in and facilitates meetings, as needed, to ensure collaboration and information is collected to make informed, critical decisions in order to resolve operational and system issues.
Assists other QC Lab groups to capture synergies, organize, and prioritize requirements to meet established goals.
Assists the implementation of processes in the Quality Control Laboratory to expedite analytical testing, improve customer service, reduce operational costs and improve laboratory safety.
Effectively communicates, exhibits the company values, maintains priorities and monitors training to ensure a high standard of performance.
Ensures that staff is trained in, and adhere to, safe operational practices to prevent accidents and avoid danger to staff and others in the workplace.
Introduces new analytical techniques/technology to the laboratory (includes staff training) and develops and validates new analytical methods when required.
Collaborates with other QC leaders/groups that may to some extent contribute to the analytical testing, meet timelines and regulatory /GMP requirements.
Collaborates with other QC leaders in an effort to develop and implement systems that will contribute/support departmental objectives/goals such as improved productivity, cycle time reduction, cost reduction, resource allocation/requirements.
Assists in reviewing analytical reports of other Microbiologists to ensure that work has been carried out according to the procedures specified in specifications and in compliance with all relevant SOP’s and Documentation conventions. Promptly notifies functional leader of any deviations.
Executes the QC timeline related to method procurement, analytical method transfer, method development/validation, technical evaluation, contract lab testing, process validation, shelf life and accelerated stability studies.
Identifies risks/concerns/issues regarding project and recommends corrective action, appropriate actions to mitigate impact to project timelines.
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