Microbiologist I

About the role

To perform quality control duties including, but not limited to, testing raw materials, in-process, and finished goods, as well as environmental monitoring of cleanrooms to support manufacturing activities.

Responsibilities

• Perform bioburden and endotoxin testing of raw material, in-process, and final product to verify compliance with specification limits.
• Generate protocols, review data, and write final reports.
• Initiate and revise SOPs, Test Methods, and Forms and other procedures to ensure compliance.
• Participate in validation testing activities involving aseptic processes, including operation of the Autoclave, Sterilization-in-Place, and Vaporized Hydrogen Peroxide.
• Provide support to the manufacturing/operations department through aseptic process simulations, bacterial retention studies, container closure integrity, SIP verifications.
• Perform TOC, Endotoxin, and Bioburden testing of High Purity water samples per USP requirements.
• Read Environmental Monitoring plates and perform microbial isolation, colony morphology, along with gram staining of recovered EM organisms.
• Assist environmental monitoring (non-viable particulates, microbiological air, and microbial surface) in Grade C & D cleanroom environments within Manufacturing area.
• Strict adherence to procedures and practices according to FDA regulations & strong emphasis on documentation according to cGMP/cGLP requirements.
• Perform any other tasks/duties as assigned by management.

Qualifications

• Minimum of Bachelor of Science degree in Microbiology or related Biological Science, or equivalent combination of education and experience.
• Up to 2 years of relevant industry experience with related quality control and quality assurance in the pharmaceutical industry.
• Capable of working independently with minimum input from management.
• Strong organizational and time-management skills with the ability to make structured decisions on a routine basis.
• Proactive, results oriented, and have strong attention to detail.
• Strong interpersonal skills with the ability to interact with all departments at all levels in a team environment.
• Able to effectively prioritize and manage multiple tasks to meet targeted deadlines.
• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Ability to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime as needed.

Physical Environment and Requirements

• Possess physical ability to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Specific vision requirements include color vision.
• Maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 25 pounds.

Pay

Expected Hourly Rate: $33.70-$35.00

Schedule

Not specified