Microbiologist I

About the role

The Microbiologist I is responsible for performing microbiological testing and quality activities to support product production, environmental monitoring, and product release in a pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements and company standards by conducting microbiological assays, analyzing trends, and accurately documenting and reporting results. The QC Microbiologist I collaborates with cross-functional teams to identify potential microbiological risks, troubleshoot deviations, and contribute to continuous improvement initiatives to maintain product quality and patient safety.

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

Responsibilities

• Ensure adherence to current Good Manufacturing Practices (cGMP), USP, EU, and FDA regulations related to microbiological testing and environmental monitoring.
• Support data integrity initiatives by accurately recording and reviewing laboratory data in accordance with company procedures and regulatory requirements.
• Assist in the qualification, validation, and calibration of microbiology laboratory instruments and test methods.
• Participate in internal and external audits by providing documentation, responding to inquiries, and implementing corrective actions as needed.
• Assist in training new microbiologists or laboratory personnel on microbiological techniques, procedures, and regulatory expectations.
• Contribute to continuous improvement efforts by identifying and implementing process efficiencies within the microbiology laboratory.
• Collaborate with cross-functional teams, including Quality Assurance and Manufacturing, to support investigations and resolve microbiological issues.
• Maintain proper storage, handling, and disposal of microbiological samples, reagents, and hazardous materials in compliance with safety guidelines.

Requirements

• Bachelor’s degree in a scientific discipline, preferably microbiology or related field
• Minimum of one (1) year of industry experience in a GMP or GLP environment, preferred
• Previous experience with pharmaceutical cleanroom environments, preferred
• Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485, and 17025, preferred
• This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• Must be able to obtain and maintain gowning certification
• Must be able to obtain and maintain media qualification
• Must be able to wear a respirator

Skills

• Provides guidance and mentorship to team members
• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
• Demonstrates strong attention to detail
• Proficient in the validation/qualification of lab microbiological techniques