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Actalent

QC Manager Microbiology

Actalent, Vernon Hills, Illinois, United States, 60061

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QC Manager Microbiology

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Actalent . Job Description

The QC Manager Microbiology is responsible for managing microbiology quality control operations, ensuring compliance with cGMP and regulatory standards. This role involves overseeing sterility, bioburden, endotoxin, and environmental monitoring testing, reviewing data for accuracy, and collaborating with Quality Assurance on investigations and SOPs. The manager will lead a team, drive continuous improvement, and ensure timely batch release decisions. Responsibilities

Manage microbiology QC team and daily laboratory operations. Review microbiology data, such as sterility, bioburden, and environmental monitoring, from LIMS/e-notebooks. Collaborate with Quality Assurance on SOPs, investigations, CAPAs, and deviations. Ensure compliance with FDA, USP, EU, and ISO guidelines. Oversee media preparation, instrument validation, and calibration. Analyze QC metrics and performance indicators for trending and batch release decisions. Conduct internal audits, training, and team mentorship. Communicate with cross-functional teams on data issues and resolutions. Essential Skills

Microbiology Bioburden CAPA Environmental Monitoring Sterility Deviations SOP Development Quality Control Laboratory cGMP Additional Skills & Qualifications

B.S. or M.S. in Microbiology, Biology, or related field. 5+ years experience in microbiology QC within cGMP environments. 2+ years experience leading a team. Work Environment

The work environment is collaborative, with a cross-functional team focus. The QC Manager will oversee daily lab operations and have two direct reports. Job Type & Location

This is a Contract to Hire position based out of Vernon Hills, IL. Pay And Benefits

The pay range for this position is $41.00 - $46.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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