Job Summary - a concise overview of the job

All incumbents are responsible for following applicable Division & Company policies and procedures.

The ideal candidate is a detail-oriented individual with excellent interpersonal skills to fill the position of Microbiologist in a Biosafety Level 2 laboratory. Candidate should have excellent aseptic technique and basic Microbiologic skills. These skills should include the ability to streak plates, serial dilute, perform gram stains, and interpret colony morphology and stain reactions under a microscope to get a basic idea of bacterial identification.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Floor

Operations

• Perform testing and sample collection per USP.
• Maintain and clean the lab and equipment per SOP.
• Work with Manufacturing/Packaging team to resolve micro issues in production areas.
• Complete identifications and biochemical testing.
• See Skills and abilities for microbiological activities.

75%

Non-Conforming Events

• Perform research and write investigations as needed.

10%

Process Improvement

• Review logbooks and documentation.

15%

Compliance

• Continuously comply with FDA, USP, CFR, and company procedures.

continuous

Safety

• Put safety first in the workplace.

continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• Bachelor of Science - Microbiology, Biology, or other related field (12 hours of Microbiology coursework preferred).
• 0-2years of previous lab experience in Microbiology or similar field.
• Laboratory Information Management (LIMS) experience a plus.

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Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Maintain current training compliance on assigned SOPs and company policies.
• Maintain knowledge of FDA regulations including pertinent USP chapters and CFR guidelines.
• General computer skills including Microsoft Suite.

Skills

Abilities

Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

• Maintain a clean, organized, and safe work area.
• Excellent aseptic technique is a requirement.
• Accurately and legibly document and record all work completed so that analyses may be fully traceable and reproducible.
• Work in cross functional teams as necessary to complete projects, transfers, and investigations as well as working independently.
• Multitask projects while maintaining high levels of accuracy.
• Ability to perform serial dilutions.
• Microbiological Activities
• Perform finished product, raw material, and stability testing
• Complete environmental monitoring of the facility using various air sampling units.
• Complete water sampling throughout the facility as well as water testing.
• Perform bacterial identification of environmental and product isolates.
• Complete media production and perform media growth promotion.

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Ability to lift-up to 40 pounds
• Ability to crouch and stand for extended periods
• Ability to walk across plant and warehouse areas