Associate Microbiologist

Natural Alternatives International Inc•Vista, CA

3d•Onsite

About The Position

Performs microbiological testing on raw materials, in-process and finished product as well as environmental monitoring samples in a cGMP/GLP laboratory. Reports results in a timely and professional manner to QC Director or designate for review.

Requirements

BA/BS degree in Microbiology, Biology, Biochemistry or related field.
Minimum 1 year experience working in a microbiological lab, preferably in a regulated GMP industry
Experience with aseptic technique, serial dilutions, quantitative enumeration of microorganisms, and preparation of test media.
Good computer skills with Microsoft Word, Access and Excel and LIMS.
Effective oral and written business communication skills
Ability to initiate and maintain QC data, documents and reports.
Ability to collaborate and communicate effectively with peers and management.
Ability to multi-task, work effectively and complete projects in a fast paced environment.

Responsibilities

Performs routine microbiological testing on raw materials, in-process and finished products using compendial methods such as USP, AOAC, FDA-BAM and in-house validated methods on the rapid automated Soleris system.
Performs retesting of out-of-specification (OOS) results as directed by QC Management.
Performs water sampling at various ports and performs bioburden, TOC, and conductivity testing.
Performs Environmental Monitoring testing (for air and surface) per established protocol.
Effectively communicates testing progress or project status to QC Management.
Prepares, packs, and sends samples for 3rd party lab testing as necessary.
Execute microbiological method qualifications and verifications protocols.
Conduct peer review of data generated in QC Microbiology.
Documents and reports result in the appropriate notebooks, logbooks, files, and databases.
Performs routine microbiological testing (pathogen testing, confirmation testing, gram staining, isolation, etc.) and prepares media and necessary dilutions for the microbiological analysis of samples as per applicable SOPs.
Performs basic lab maintenance, such as: laboratory/equipment cleaning, lab stocking and organize preventive maintenance and inventory management, etc.
Performs timely disinfection and handling of biohazard and general wastes.
Assists with maintaining up-to-date supplies and media inventory for the micro lab.
Provides backup support to the Microbiologist or designee on day-to-day activities or tasks, as directed by QC Lab Director.
Performs special projects as assigned by QC Lab Director.
Provides guidance and direction to new or backup lab members.
Complies with cGMP, cGLP, FDA and other applicable industry regulations as well as NAI policies.