Microbiologist II - Non-Sterile

About the role

The Microbiologist II performs routine microbiological testing to ensure product safety and regulatory compliance. This role includes quality control and quality assurance of materials and products, requiring an advanced understanding of USP, cGMP, ISO 17025, and other applicable regulatory requirements.

Responsibilities

• Perform and result routine microbiological testing on samples in a timely manner, independently with some supervision, to meet assigned testing deadlines.
• Ensure accuracy and validity of results in accordance with SOPs and regulatory standards.
• Interpret test results to determine pass/fail status and escalate unexpected findings to senior staff.
• Record, report, and investigate unexpected test results with some supervision.
• Prepare samples, reagents, and media for daily testing activities.
• Support sample receipt and chain of custody documentation.
• Regularly handle BSL-1 and BSL-2 regulated microorganisms following proper safety and workflow practices.
• Maintain current and accurate documentation in compliance with GMP and GDP standards.
• Clean, organize, and maintain laboratory workspaces and equipment to ensure readiness and compliance.
• Perform standard operational maintenance and minimal troubleshooting of assigned equipment and systems to confirm equipment is operational prior to use. Notify supervisor and engineering promptly of calibration failures and repair needs.
• Ensure proper disposal of biohazard waste in accordance with SOPs.
• Comply with company policies and all applicable SOPs; adhere to ISO 17025, BSLT-2 cGMPs, cGLPs, A2LA requirements, and Quality Control Guidelines.
• Participate in training sessions and cross-technology educational programs to expand technical knowledge and proficiency in advanced microbiological techniques.
• Stay abreast of current technology and instruments, with emphasis on microorganisms, equipment troubleshooting, and microbiology/taxonomy issues.
• Provide technical assistance and back-up support across laboratory workstations as required.
• Overtime and occasional weekend hours may be required.
• Assist with laboratory compliance audits and laboratory safety audits.
• Perform more complex testing on samples (method suitability modifications, method development, etc.)
• Support supervisor or project microbiologists in validation activities as assigned.
• Accurately identify, monitor, and report microbiological trends.
• Assist in revising and reviewing compliance with all Standard Operating Procedures (SOPs).
• Maintain familiarity with use of all applicable equipment, systems, and procedures (SOPs).
• Manufacturing and quality control testing for in-house media production.
• Aseptic production and quality control of BSL-1 and BSL-2 microbial stocks.
• Lead the microbiology staff in the execution of special projects, as needed.
• Train and mentor microbiology staff.

Requirements

• Bachelor’s degree in microbiology or related science field, including at least 12 semester hours of hands-on laboratory courses in microbiology and/or chemistry.
• With 3-5 years of pharmaceutical/biochemical QC laboratory experience in microbiology. Or master’s degree in microbiology or related science field.
• With 2-3 years of pharmaceutical/biochemical QC laboratory experience in a microbiology lab.
• Demonstrated relevant experience in a microbiology laboratory (Q.C., pharmaceutical, biotech or clinical lab experience preferred), where one or more of the following functions was successfully performed: microbial enumeration testing, growth promotion testing, streak for isolation, testing with microorganisms, environmental monitoring, method suitability, microbial identification, gram staining, pipetting small volumes, SOP/documentation revisions, or other applicable testing/skills.
• Excellent analytical, decision making and interpersonal skills.
• Excellent verbal and written communication skills.
• Excellent working knowledge and understanding of microbiology principles and methods and the ability to communicate this information to others.
• Physical dexterity to perform testing accurately and precisely.
• Ability to read, understand and comply with Company policies and SOPs, including safety rules and regulations.
• Ability to work independently, with minimal supervision.
• Intermediate level computer skills in Microsoft Office, Word, Excel, Outlook, and PowerPoint.
• Ability to adapt, learn, and teach new skills as needed.
• Can work within a team to achieve the same goal.
• Ability to multitask within a single task and multiple tasks when applicable.
• Ability to solve routine and non-routine laboratory issues/problems.

Skills

• Virology and Fibology
• SOP creation and implementation

Qualifications

• Education Preferred: Bachelors or better in Microbiology or related field.
• Experience Required: Virology and Fibology
• SOP creation and implementation
• 3 years: Pharmaceutical/Bio-Chemical QC Laboratory experience Preferred
• 2 years: GMP and or cGMP

Benefits

Not specified

Pay

Not specified

Schedule

Not specified