Senior Microbiologist, Quality Control

Senior Microbiologist, Quality Control

As a Senior Microbiologist, Quality Control, you will play a key role in ensuring compliance with environmental regulations and Good Manufacturing Practices (GMP) by performing microbiological testing within a biopharmaceutical manufacturing organization. You will utilize advanced technology to monitor air, water, and surfaces for potential contaminants, perform growth promotion and bioburden testing, and support environmental monitoring activities.

You will also review and trend data, generate reports, and maintain laboratory inventory. Your work will directly support the production of life-saving biopharmaceuticals and contribute to public health and environmental safety.

Key Responsibilities

• Perform bioburden testing of water and in-process samples per USP and EP requirements, including Gram staining of recovered microorganisms

• Read environmental monitoring (EM) plates and document results

• Perform growth promotion testing

• Perform trending in LIMS (MODA or LabWare)

• Maintain inventory of department supplies and place purchase orders

• Inoculate microbial cultures for growth promotion testing

• Prepare cultures for microbial identification as needed

• Support investigations for EM out-of-limit (OOL) results, including notification and re-testing of alert and action limits

• Perform data review of environmental monitoring results and assist in preparing trending reports

• Monitor temperatures of Manufacturing and Microbiological QC refrigerators, freezers, cryo-freezers, and cold rooms

• Perform other duties as assigned

Minimum Qualifications

• B.S. in Microbiology or related field with 4–5 years of experience in a GMP microbiology laboratory
  OR

• M.S. in Microbiology or related field with 1–3 years of relevant experience

Required Experience

• Routine bioburden testing of water systems, raw materials, in-process materials/components, and finished products

• Gram staining and colony morphology analysis

• Aseptic microbiological techniques to prevent contamination and cross-contamination

• Trend report and/or protocol writing

• Supporting investigations to determine root cause and corrective actions

• Growth promotion testing

• Knowledge of aseptic techniques and behavior

• Strong understanding of cGMP requirements and experience working in controlled environments

• Experience with LIMS (preferably LabWare and/or MODA)

• Working knowledge of USP, EP, and Annex 1

Position Type / Expected Hours

This is a full-time position with a Sunday through Wednesday schedule, working four 10-hour shifts. Typical operating hours are 7:00 a.m. to 6:00 p.m.

Compensation

We offer a competitive compensation package including base salary, performance-based bonuses, and comprehensive benefits such as medical, dental, and vision insurance, 401(k) matching, and paid time off.

The salary range for this role is $65,800 to $75,000 annually, depending on experience and qualifications. We also provide opportunities for career growth and a supportive, inclusive work environment.

Who You Are

• A collaborative team player with a positive, solution-oriented mindset

• An effective communicator with strong written and verbal skills

• Highly organized with excellent multitasking abilities and attention to detail

• Skilled at building strong working relationships with team members, clients, vendors, and suppliers

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