Description
Position Title: Quality Control Environmental Monitoring Manager
Location: Clayton, NC
Schedule: Monday – Friday | 8:00 AM – 5:00 PM
Salary Range: $120,000 – $165,000
This role is responsible for the comprehensive management of the Quality Control (QC) Environmental Monitoring (EM) laboratory. The position oversees quality systems, documentation, laboratory operations, regulatory compliance, employee development, staffing, training, and budget.
Primary Responsibilities:-
Lead and manage all aspects of the QC Environmental Monitoring unit:
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Quality systems
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Documentation and data integrity
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Laboratory operations
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Regulatory compliance (GMP/GxP)
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Budget planning and oversight
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Employee relations and staffing
Ensure compliance with cGMP regulations and department safety standards.
Provide expert guidance to manufacturing and regulatory departments on GxP-related matters.
Make informed, independent decisions within the defined scope of responsibility.
Plan, delegate, and prioritize tasks to meet project timelines and budgets.
Represent the department during internal and regulatory audits:
Present EM data
Respond to audit findings
Author or contribute to written responses and corrective action plans
Investigate quality issues and initiate corrective/preventive actions (CAPA).
Uphold high standards of integrity, leadership, and operational excellence.
Key Responsibilities:-
Manage environmental monitoring activities for facilities, utilities, and aseptic/sterile fill lines.
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Author, review, and approve department SOPs, reports, and investigations.
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Lead process improvements through change control and continuous improvement initiatives.
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Serve as system administrator for EM laboratory control systems (e.g., SAP), ensuring timely reporting and availability of test results.
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Act as the subject matter expert (SME) in environmental monitoring for cross-functional teams, audits, and investigations.
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Support regulatory and internal inspections through direct engagement, data analysis, and formal documentation.
Education & Experience (one of the following):
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PhD in Life Sciences or related field + minimum 6 years of relevant experience
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MS in Life Sciences or related field + minimum 8 years of relevant experience
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BS in Life Sciences or related field + minimum 10 years of relevant experience
Preferred Experience:
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Experience interfacing with the FDA, including license submissions, inspections, and audit follow-up
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Background in aseptic/sterile manufacturing environments
Note: Equivalent combinations of education and experience may be considered.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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