What are the responsibilities and job description for the QC Microbiology Analyst position at directpathrecruitingservices?
Duties and Responsibilities
Utilities Sampling : Perform routine sampling and analysis of Water for Injection, Purified Water, Clean Steam, and Process gases to ensure compliance with regulatory standards.
Environmental Monitoring : Conduct environmental monitoring of classified cleanroom suites and laboratory areas to maintain compliance with cGMP and FDA regulations.
Microbiological Testing : Execute microbiological tests, including bioburden, endotoxin, sterility, and microbial identification, for In-Process, Drug Substance, Drug Product, and Stability samples.
Operational Support : Support QC operations such as instrument qualification and maintenance, SOP creation and updates, specification revisions, and accurate recordkeeping.
Inventory Oversight : Manage and maintain laboratory supplies, reagents, and consumables to ensure uninterrupted operations.
Investigations : Conduct thorough laboratory investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT) results, deviations, and invalid assay troubleshooting.
Corrective and Preventive Actions : Develop and implement CAPAs to address identified issues and prevent recurrence.
Facility Qualification : Participate in facility and equipment qualification activities, including microbiological testing and environmental monitoring validations.
Gowning and Physical Activities : Adhere to gowning requirements for cleanroom entry and perform tasks requiring extended periods of standing and mobility.
Method Transfer and Validation : Assist with method transfer, protocol execution, and validation activities, including preparation and documentation.
Additional Duties : Perform other responsibilities as assigned by the management team.
Education :
Bachelor’s degree in Microbiology, Biology, or a related scientific field is required.
Experience :
Minimum of 2 years in a QC microbiology role within an FDA-regulated biotechnology or pharmaceutical environment.
5 years of experience is preferred if higher education is not applicable.
Technical Expertise :
Strong knowledge and hands-on experience with microbiological testing methods such as endotoxin, bioburden, sterility, microbial identification, PCR, and environmental monitoring.
Familiarity with regulatory standards, including USP / EP, cGMP, and EU GMP.
Experience with instrument and equipment validation processes.
Soft Skills :
Excellent written and verbal communication skills for effective interaction across all levels of the organization.
Proven ability to work independently and collaboratively in a fast-paced, regulated environment.
Compensation / Duration : Up to $50 / hr and it is a 6 month contract
Salary : $50
