GMP Microbiologist: Lab Testing, Mentorship & Growth

Comunidade Metodista; Vista (CA); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Free medical

Retention bonus after 90 days

Employee referral bonus

3 weeks vacation and 11 paid holidays

401K with company match and profit分享

Tuition reimbursement

Job summary

NAI is seeking a microbiologist to perform routine microbiological testing on raw materials, in-process and finished products in a cGMP/GLP laboratory. The role reports to the QC Director and supports environmental monitoring, water testing, and data documentation.

Candidates will have a BA/BS or MSc in related fields, strong aseptic technique, experience with Bioburden and environmental monitoring, and solid computer skills including LIMS.

Qualifications

• BA/BS degree in microbiology, chemistry, biology, biochemistry or related field with minimum 3 - 5 years' experience working in a microbiological laboratory lab, preferably in a regulated GMP industry
• MSc degree in microbiology, biology, chemistry, biochemistry or related field with a minimum of 1 year experience working in a microbiological lab, preferably in a regulated GMP industry
• Proficiency in aseptic technique, serial dilutions, quantitative enumeration of microorganisms, and preparation of test media
• Experience with microbiological testing such as Bioburden and environmental monitoring
• Good computer skills with knowledge of Microsoft Word, Access and Excel. LIMS experience preferred
• Effective oral and written business communication skills
• Ability to initiate and maintain QC data, documents, reports and corrective action summaries
• 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, assists with OOS investigations and OOS reports as directed by QC Director/designee
• Performs water sampling at various ports and performs bioburden, TOC and conductivity testing
• Performs Environmental Monitoring testing (for air and surface) per established protocol
• Reviews water and EM test results and assists in investigation of excursions and preparation of relevant reports as directed by QC Director/designee
• Effectively communicates testing progress or project status to QC Director/designee
• Documents and reports result in the appropriate notebooks, databases and LIMS
• Performs formal review of peer notebooks and test results
• Prepares media used for the microbiological analysis of samples
• Performs timely cleaning and disinfection and handling biohazard and general wastes
• Maintains supplies and media inventory for the micro lab in collaboration with the Lab Coordinators by creating needed Purchase Requisitions Forms and formally qualifying received media and reagents
• Operates, maintains and ensures calibration of equipment including thermometers, analytical balances, pipettes and other related equipment used in the micro lab; notifies QC Supervisor of potential issues
• Assists with new equipment qualification/ validation projects as directed by QC Director/designee Assists in developing or revising microbiological test methods
• Trains and mentors Associate Microbiologists and Micro Technicians
• Reviews and revises Standard Operating Procedures (SOP) as directed by QC Director/designee
• Assists in implementing cGMP/GLP programs and procedures within the micro laboratory
• Provides backup support to QC Director/designee on day to day activities or tasks, as required
• Performs special projects as assigned by QC Director/designee
• Complies with cGMP, cGLP, FDA and other applicable industry regulations as well as NAI policies

Skills

Aseptic technique

Bioburden testing

Environmental monitoring

LIMS experience

Microsoft Word/Excel/Access

Oral and written communication

Multitasking

Team collaboration

Education

BA/BS in microbiology or related field

MSc in microbiology or related field

Tools

Soleris system

LIMS

Job description

NAI is seeking a microbiologist to perform routine microbiological testing on raw materials, in-process and finished products in a cGMP/GLP laboratory. The role reports to the QC Director and supports environmental monitoring, water testing, and data documentation.

Candidates will have a BA/BS or MSc in related fields, strong aseptic technique, experience with Bioburden and environmental monitoring, and solid computer skills including LIMS.