Microbiologist II

American Regent•Brea, CA

9d•Onsite

About The Position

This role performs quality control duties including testing raw materials, in-process, and finished goods, as well as environmental monitoring of cleanrooms to support manufacturing activities. The position requires strict adherence to procedures and practices according to FDA regulations and a strong emphasis on documentation according to cGMP/cGLP requirements.

Requirements

Minimum of Bachelor of Science degree in Microbiology or related Biological Science, or equivalents combination of education and experience.
2-4 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.
Must be 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.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
Physically able 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.
Employees must 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.

Responsibilities

Perform bioburden and endotoxin testing of raw material, in-process, and final product to verify that material comply to specification limits. Testing includes Microbial Enumeration, Endotoxin, Gram Stain Analysis, and Growth Promotion.
Coordinate sample submission to third party contract testing facilities.
Ordering laboratory supplies and maintaining inventory.
Assist in the development, optimization, and validation of microbiological test methods.
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. This includes operation of the Autoclave, Sterilization-in-Place, 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.
Assist in reviewal of data generated by department technicians.
Assist management in data analysis and trending reports.
Training of new hires.
Perform any other tasks/duties as assigned by management.