Microbiologist *PC 609

About the Role

This position is primarily responsible for performing environmental and process-related monitoring at various stages of the production process. The role also involves initiating deviations and Out Of Specification (OOS) reports associated with microbiological testing, as well as participating in process and laboratory improvements, such as the development of procedures and studies.

Responsibilities

• Perform environmental and process-related monitoring at various stages of the production process.
• Initiate deviations and Out Of Specification (OOS) reports associated with microbiological testing.
• Support inventory management, filing, and record keeping.
• Ensure all equipment is properly maintained and calibrated.
• Perform, manage, and enhance sterility testing of final drug product in accordance with compendial methods.
• Participate in process and laboratory improvements, such as development of procedures and studies (e.g., 5S, Kaizen, Six Sigma) and execution of protocols, method validations, and other assay developments.
• Support the QC Microbiology laboratory with enumerating and trending of environmental monitoring (EM) samples, raw material testing support, and coordination of samples for external testing.
• Collaborate with Sample Management on sending required samples to contract testing laboratories or other recipients.
• Collaborate with QC Analytical Management in establishing product specifications.
• Establish user requirements for the purchase of new Miltenyi GMP equipment.
• Assemble and report contract laboratory testing data.
• Perform data entry for tracking and trending of lab reports.
• Count, record, and report colonies and growth from EM, AOQ, and APS plates and samples.
• Complete routine record and test data review.
• Coordinate daily scheduling of tests and activities, including but not limited to EM, Gram stain, growth promotion, and sterility.
• Participate in environmental investigations.
• Support team enhancements and developments for laboratory methods as needed.
• Assemble and report quarterly, annual, and customized trend reports for environmental monitoring, personnel monitoring, excursions, and out-of-trend data in support of continuous improvement.
• Other duties as assigned.

Requirements

• Bachelor’s degree in Biology, Microbiology, or other life sciences.
• 5+ years of experience working in a QC Microbiology laboratory or similar GMP setting.
• Domestic travel requirements: 10% or less.

Skills

• Working knowledge of controlled documentation, data systems, cGMPs, SOPs, microbiological testing, and auditing.
• Proficient in MS Office products including Word, Excel, Outlook, and PowerPoint.
• Strong technical knowledge in various microbiological techniques, including rapid release methods, environmental qualifications, and cellular therapy-based products.
• Experience in the application of microbiological techniques such as air monitoring, surface monitoring, and genus and species identifications.
• Working knowledge of quality systems and regulatory requirements (including 21 CFR Part 11/210/211).
• Experience identifying, authoring, and supporting OOS and deviation reports (DRs).
• Ability to work in a fast-paced environment with minimal direction and adjust to a dynamic work environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear.
• Required to stand; climb or balance; and stoop, kneel, or crouch.
• Must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Ability to handle more than one task at a time and work at a rapid pace while maintaining attention to detail.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• Performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures.
• Generally performed in a clean laboratory setting, routinely using standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes, and computers.
• Exposure to viruses and bacteria; appropriate clothing and protective equipment such as lab coats, glasses, and gloves are required.
• The noise level in the work environment is usually moderate.

Pay

The hiring range for this position is expected to fall between $47.29 - $55.63 per hour, reflecting the range candidates can reasonably expect to be considered for at the time of offer, based on factors such as experience, internal equity, and qualifications. The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training.

Benefits

• Comprehensive benefits package, including health, vision, and dental insurance.
• 401(k) plan (all benefits are subject to eligibility requirements).
• Certain positions may also be eligible for additional compensation such as bonuses or commissions.