Microbiologist

You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

The microbiologist is responsible for performing microbiological testing, environmental monitoring, and microbial limit testing to ensure the sterility and compliance of compounded sterile preparations in accordance with cGMP / USP / FDA 503B regulatory requirements. This role supports the QC Laboratory's analytical and environmental control programs, contributing to the overall assurance of product quality and patient safety.

Key Responsibilities

• Develop and implement quality control standards and guidelines.
• Daily microbial testing.
• Support/Lead OOS/OOT investigations and customer complaints.
• Support Deviations/CAPA/Change Control; implement lab CAPAs and effectiveness checks.
• Partner with Sterility Assurance and execute EM sampling/reading/ID and reports.
• Maintain relationships with external laboratories, vendors, and suppliers.
• Manage reference standards, reagents, and solution traceability; verify supplier CoAs; maintain reserves/retains.
• Oversee USP Sterility, Endotoxin (LAL), bioburden, growth promotion, positive controls, and microbial identification.
• Execute growth promotion testing, media fills, microbial ID, etc.
• Support method validation, equipment qualification, personnel qualification, and cleanroom qualification activities.
• Qualify/monitor incubators and controlled units; ensure media lot traceability and quarantine/release.
• Ensure EM results are reviewed/trended on schedule; immediately notify SA/QA on alerts/actions and support containment.
• Issue accurate, timely CoAs following independent review; maintain sample chain-of-custody.
• Assist in audits, regulatory inspections, and training of QC laboratory personnel.
• Other duties as assigned.

Qualifications

• BS/BA in Biology, Microbiology, Biochemistry, Pharmacy, or related (MS preferred).
• 2+ years QC experience in sterile pharmaceuticals or 503B.
• Hands-on with USP , , (plus / as applicable).
• Proven OOS/OOT leadership, strong technical writing, and inspection participation.
• Working knowledge of 21 CFR 210/211, Part 11, FDA Aseptic Processing Guidance, and 503B cGMP expectations.
• Gown Qualified for ISO 7/8 (and observe ISO 5), support off-hours testing as needed.

Skills

• Technical Skills: Proven expertise with microbiological testing and regulatory compliance.
• Soft Skills: Strong leadership, technical writing, and teamwork abilities.

Additional Requirements

• Experience with rapid micro/ID techniques.
• Strong understanding of aseptic technique and contamination control principles.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

* We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we're dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

* As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.