Quality Control Associate, Microbiology

Microbiology Quality Control Specialist ($27-$32/hr)

Position Summary

This full-time, on-site role is responsible for supporting and managing a microbiology program within a GMP-regulated Drug Product Manufacturing environment. Key responsibilities include oversight of aseptic fill/finish activities, environmental monitoring, gowning qualifications, and execution of compendial microbiology assays (endotoxin, bioburden, sterility). The role ensures all operations meet applicable cGMP standards and supports various quality control functions including audits, investigations, and process validations.

Location: 100% On-Site

Schedule: Monday â Friday, 8 hours/day (excluding lunch break)

Start Time: Flexible between 6:00 AM â 9:00 AM (consistent schedule required)

Additional Hours: Overtime, weekends, and holidays may be required

Note: Schedule changes must be pre-approved by management

Key Responsibilities

Serve as a Subject Matter Expert (SME) for microbiological assays/methods during audits, risk assessments, and investigations

Support assay transfer, qualification, and validation activities for microbiological or client-specific methods

Author, review, and revise QC SOPs, protocols, and reports

Conduct testing on in-process samples, APIs, raw materials, and stability samples

Perform routine and non-routine environmental monitoring (EM) for particulates, air/surface viables in GMP/GLP facilities

Investigate environmental monitoring excursions and assess impact on product quality

Support and maintain a Gowning Qualification Program

Conduct monitoring of pharmaceutical water and gas systems

Execute Bioburden, Growth Promotion, Endotoxin, Gram Stain, TOC, Conductivity, Microscopy, and Nitrate testing

Maintain and calibrate QC lab equipment; assist in equipment and facility qualification

Trend EM data and generate quarterly and annual reports

Participate in inspection readiness activities

Collaborate cross-functionally to ensure timely and compliant project execution

Manage lab operations including inventory, ordering, housekeeping, and general support

Contribute to investigations related to deviations, non-conformances, and audits

Support training of QC personnel and participate in special projects as assigned

Operate with a high level of ethical and regulatory compliance

Promote a safety-first culture and follow all lab safety protocols

Continuously support quality improvements and client-driven initiatives

Qualifications

Education & Experience:

Bachelorâ s degree in Microbiology, Biology, Chemistry, or related discipline preferred (or equivalent coursework and experience)

Minimum 3 years of experience in Quality Control and environmental monitoring in a GMP-regulated environment

Experience with compendial methods such as Bioburden, Endotoxin, Growth Promotion, and Sterility required

Hands-on experience with large molecule analytical method transfer and validation preferred

Prior exposure to aseptic processing, cleanroom practices, and root cause investigations strongly preferred

Familiarity with quality systems and 21 CFR Part 11-compliant software a plus

Skills & Attributes:

Strong analytical and problem-solving skills

Excellent written, verbal, and listening communication abilities

High personal integrity and professional reliability

Ability to work independently with minimal supervision

Proficient in Microsoft Office (Word, Excel, Outlook)

Ability to multitask, prioritize workload, and accurately interpret and document results