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