Microbiologist III - Night Shift

About the role

The Quality Control Microbiologist III is responsible for performing advanced 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.

Responsibilities

• Perform microbiological testing (endotoxin, sterility, and bioburden) for raw materials, in-process materials, intermediates, and final products.
• Conduct microbiological testing (endotoxin, bioburden) for utilities such as water, steam, nitrogen, etc.
• Perform environmental monitoring of cleanrooms in compliance with USP and EU specifications.
• Review, trend, and report results for environmental, personnel, in-process, raw material, finished product, and utilities testing.
• Conduct microbial characterization (gram stain, catalase, oxidase, and coagulase tests) and prepare and send out samples for microbiological identification.
• Maintain historical files for organisms found in classified areas, including microbial identification and trending.
• Perform line clearances and line start verifications, as well as inspections of media fills.
• Serve as the Subject Matter Expert (SME) for microbiological assays such as sterility (including biological indicator testing) and growth promotion testing for all incoming media used in the microbiology laboratory.
• Perform microbial limits/enumeration testing and handle QC microbiological sample receipt, including internal testing, logging, processing, tracking, distribution of test results, and closure.
• Author and revise controlled documents, including Standard Operating Procedures (SOPs), Investigational Protocols, Risk Assessments, and others as needed.
• Initiate Out of Specification (OOS) or Environmental Monitoring Excursion investigations, recommend appropriate Corrective and Preventive Actions (CAPAs), and complete effectiveness checks.
• Oversee equipment cleaning and maintenance, including managing supplies and inventory.
• Act as a liaison with vendors for maintenance, preventive maintenance (PM), and calibration of equipment.
• Ensure general laboratory housekeeping and maintain a clean, organized workspace.
• Facilitate the revision and release of all controlled documents in a timely manner.
• Cover mandatory reviews of SOPs and month-end reports, ensuring they are completed on schedule.
• Read/interpret SOPs to ensure compliance.
• Maintain up to date trainings.

Requirements

This role requires a Bachelor’s degree in a scientific discipline, preferably microbiology or related field, with a minimum of five (5) years related work experience and a minimum of three (3) years industry experience in a GMP or GLP environment. Previous experience with pharmaceutical cleanroom environments is preferred. Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485, and 17025, preferred. Experienced and proficient in the validation/qualification of lab microbiological techniques, preferred. Supervisory responsibilities are not applicable for this role.

Qualifications

• Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.
• Strong written and verbal communication skills, along with effective presentation skills.
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Adeptness in manufacturing and internet software, proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
• 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, follows established safety protocols, participates in safety training programs, and fosters a culture of awareness and responsibility among team members.
• Strong attention to detail, strong GDP acumen, provides oversight for projects to update/maintain official document templates, directs and manages the Change Control System, proficient in using spreadsheets for data entry, basic calculations, and organizing microbiological data.

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
• Provides oversight for projects to update/maintain official document templates
• Directs and manages the Change Control System
• Proficient in using spreadsheets for data entry, basic calculations, and organizing microbiological data

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

And more!

Pay

Competitive compensation package based on experience and qualifications

Schedule

Full-time position