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

Job Summary

Our client is seeking a Quality Assurance Manager to own the Contamination Control Strategy (CCS) and the Environmental Monitoring (EM) program for their site. This role includes leading prevention, detection, and response to contamination risks across various aspects such as people, process, facilities, utilities, and materials. The position involves defining return-to-service criteria after excursions, leading Aseptic Process Simulations (APS/media fills), and partnering with QA Ops, QC Micro, Validation, and Facilities to maintain site control and ensure a compliant, reliable supply.

Key Responsibilities

• Maintain and own the site CCS, including people/material flows, disinfection programs, and barrier behaviors.
• Define limits for environmental and support parameters like viable/non-viable, pressure differentials, and temperature conditions.
• Manage and oversee the EM program, ensuring effective sampling plans and data review.
• Lead EM/aseptic investigations and effectively contain contamination, driving corrective and preventive actions (CAPA).
• Own and manage APS/media fills design and execution.
• Define cleaning and disinfection program effectiveness, assessing disinfectant efficacy and planning rotations.
• Collaborate on container-closure integrity strategies and ensure inspection processes capability.
• Serve as an SME during inspections and maintain related SOPs.
• Train and mentor team members, coaching behaviors on the floor.
• Publish and present quality metrics and governance structures.

Qualifications

• BS/BA in Microbiology, Biology, Pharmacy, Engineering (MS preferred).
• 7+ years in sterile drug manufacturing, with 3+ years leading sterility assurance/EM.
• Hands-on experience with CCS, EM programs, and APS/media fills.
• Demonstrated leadership in EM/aseptic investigations and site return-to-service processes.
• In-depth knowledge of 21 CFR 210/211 regulations and relevant FDA guidance documents.
• Proven skills in technical writing and training, with inspection SME competencies.
• Ability to gown to ISO 5/7 standards.

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.