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QA Microbiologist II

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The QA Microbiologist II performs microbiological testing and analysis of raw materials, pharmaceutical products, environmental samples, and finished products while ensuring data integrity, cGMP compliance, and appropriate product release. This role supports laboratory equipment maintenance, technician training, investigations, procedures, and microbiology-related projects, contributing directly to the quality and safety of pharmaceutical products in a highly regulated environment.

Responsibilities

• Conduct routine microbiological testing for water, bulk pharmaceutical chemicals, drug products, and finished products, and assess results according to approved test methods and work instructions.
• Perform method suitability testing on finished products using traditional microbiological methods, document results clearly, and report findings in accordance with procedures.
• Sample and test water, environmental air, and surfaces, then analyze, report, and trend data to support environmental monitoring programs.
• Conduct aseptic sampling for evaluation of compressed air and cleaning and sanitization processes to verify control of the manufacturing environment.
• Perform basic identification of microorganisms to support product quality investigations and environmental monitoring assessments.
• Prepare microbiological media used in testing bulk pharmaceutical chemicals, drug products, and components, ensuring suitability for intended use.
• Perform growth promotion testing for purchased and prepared media to confirm performance and reliability.
• Sample raw materials and finished products aseptically for microbial testing, following strict aseptic technique and cGMP requirements.
• Assist in the maintenance, calibration, and certifications of laboratory equipment to ensure accurate and reliable testing.
• Train and qualify technicians and microbiologists on testing procedures and techniques, and oversee data entry into electronic systems or laboratory notebooks.
• Review data generated by microbiologists in a timely manner and ensure ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) are consistently applied.
• Collaborate with third-party laboratories to ensure specifications are communicated, results are received, reviewed, and processed appropriately.
• Support LIMS-related activities and special projects specifically focused on microbiology and laboratory process improvements.
• Write scientifically sound microbiology investigation reports, non-conformance evaluations, and root cause investigations that meet regulatory and internal standards.
• Write or update Standard Operating Procedures (SOPs) to ensure they remain current and compliant with regulatory requirements and industry best practices.
• Ensure all laboratory activities maintain compliance with current Good Manufacturing Practices (cGMP), cleanliness standards, and data integrity requirements at all times.
• Prepare samples for shipment to external contract laboratories for microbiological testing, ensuring proper documentation, packaging, and chain of custody.
• Participate in investigations, non-conformance assessments, document revisions, and technical writing activities to support continuous improvement and upskilling.

Essential Skills

• Bachelor's degree in Biology, Microbiology, Chemistry, or a related science from an accredited college or university.
• A minimum of 3 years of professional experience in a pharmaceutical microbiology environment, or an equivalent combination of training and experience.
• Strong understanding of Current Good Manufacturing Practices (cGMP) and Food and Drug Administration (FDA) regulations relevant to pharmaceutical microbiology.
• Proficiency in traditional microbiology techniques, including gram staining, streak plating, culture maintenance, and aseptic techniques.
• Knowledge of United States Pharmacopeia (USP) chapters related to microbiology, including USP <60>, USP <61>, and USP <62>.
• Ability to perform gram staining and aseptic techniques accurately and consistently in a regulated laboratory environment.
• Experience with USP methods and microbiological testing in a pharmaceutical setting.
• Proficiency in reading, writing, and speaking English, with the ability to understand and apply company policies and procedures, including safety rules and regulations.
• Ability to work in a fast-paced, highly regulated environment while maintaining accuracy and attention to detail.

Additional Skills & Qualifications

• BS or MS degree in Microbiology or a related field is highly relevant and preferred.
• Experience working in a regulated pharmaceutical environment with environmental monitoring responsibilities.
• Familiarity with LIMS and electronic data systems used in laboratory operations.
• Experience supporting investigations, non-conformances (NONCs), and document revisions.
• Interest in and aptitude for technical writing, with opportunities to develop and refine these skills on the job.
• Ability to apply root cause analysis methodologies in microbiology investigations.
• Strong organizational skills to manage documentation, SOP updates, and training records.
• Commitment to maintaining data integrity and applying ALCOA principles in all laboratory work.
• Benefits include eligibility for an annual target bonus, comprehensive medical, dental, and vision coverage, and a 401(k) plan with matching contributions.
• Opportunity to join a growing organization with ongoing investment in upskilling, professional development, and career growth.

Work Environment

This is a full-time, onsite position in a microbiology laboratory and aseptic environment, operating Monday through Friday. The standard shift for this role is 12:00 p.m. to 8:30 p.m., with training potentially taking place on a day shift schedule. The work is performed in a fast-paced, highly regulated pharmaceutical setting that requires strict adherence to cGMP, FDA, and safety standards..

This is a Permanent position based out of Orangeburg, NY.

The pay range for this position is $60000.00 - $68000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Medical, behavioral & prescription drug coverageHealth Savings Account (HSA)DentalVision401(k) savings plan with company match and profit sharingBasic and supplemental Life and AD&D insuranceFlexible Spending Accounts (FSAs)Short & long-term disabilityEmployee Assistance Program (EAP)Health Advocacy ProgramLegal servicesCritical illnessHospital indemnityAccident coverageID theft and fraud protectionPet insuranceEmployee discountsPaid sick & safe leaveVacationCompany & floating holidaysPaid parental leave

This is a fully onsite position in Orangeburg,NY.

This position is anticipated to close on Sep 2, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.