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Sterility Assurance Jobs (NOW HIRING)

Kelly Services

Sterility Assurance Lead

Raleigh, NC · On-site

$90K - $110K/yr

The Sterility Assurance Lead is responsible for leading and maintaining site-wide sterility assurance and contamination control programs within a sterile pharmaceutical manufacturing environment.

Kelly Services

Sterility Assurance Lead

Raleigh, NC

$90K - $110K/yr

The Sterility Assurance Lead is responsible for leading and maintaining site-wide sterility assurance and contamination control programs within a sterile pharmaceutical manufacturing environment.

Guerbet

Sterility Assurance Lead

Raleigh, IL · On-site

Sterility Assurance Lead WHAT WE ARE LOOKING FOR Under the direction of the Site Quality Manager, the Sterility Assurance Manager is responsible for leading the site's sterility assurance program ...

Elanco

Sterility Assurance Advisor

Fort Dodge, IA

Sterility Assurance & Contamination Control Strategy As Sterility Assurance & Contamination Control Strategy , you will serve as the site's technical authority for contamination control and sterility ...

Biosimilar Sciences PR LLC

PR · On-site

Sterility Assurance Lead Location : CII George Sanders Facility, Aguadilla Pueblo, Aguadilla, Puerto Rico 00603 About OcyonBio OcyonBio is a biotechnology company based in Aguadilla, Puerto Rico ...

Biovire

Manager of Sterility Assurance

Brighton, MI · On-site

$107K - $129K/yr

The Manager of Sterility Assurance role will function in three capacities: 1) Oversight, maintenance, and SME of the Environmental Monitoring and Aseptic Process Simulation Programs. 2) Manage ...

Cardinal Health

Sterility Assurance Program Leadership: Leading and maintaining the site's Sterility Assurance Program to ensure compliance with cGMP regulations, USP standards, and internal quality requirements

Orano

Sterility Assurance Technician

Brownsburg, IN · On-site

We are seeking a detail-oriented Sterility Assurance Technician with expertise in microbiology to ensure compliance with regulatory standards and maintain cleanliness in the Orano Med pharmaceutical ...

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Sterility Assurance information

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How much do sterility assurance jobs pay per hour?

As of Jul 27, 2026, the average hourly pay for sterility assurance in the United States is $44.87, according to ZipRecruiter salary data. Most workers in this role earn between $36.54 and $54.57 per hour, depending on experience, location, and employer.

What is a Sterility Assurance job?

A Sterility Assurance job focuses on ensuring that pharmaceutical, medical device, and biotechnology products are free from microbial contamination. Professionals in this role develop, implement, and monitor sterilization processes, environmental controls, and microbial testing programs to comply with regulatory standards. They work closely with manufacturing, quality, and regulatory teams to maintain product safety and efficacy. Their responsibilities also include risk assessments, audits, and validation of sterilization techniques to meet industry guidelines.

What are the typical challenges faced by professionals in Sterility Assurance roles?

Professionals in Sterility Assurance often encounter challenges such as maintaining strict adherence to regulatory standards, quickly responding to deviations in sterility or contamination events, and ensuring continuous improvement in aseptic practices. The role requires ongoing collaboration with manufacturing, quality, and laboratory teams to troubleshoot issues and implement corrective actions. Additionally, staying up to date with evolving regulatory guidelines and technological advancements is essential for ongoing success. While these challenges can be demanding, they also offer opportunities to develop expertise and advance within the quality and compliance fields.

What jobs in the US pay 300,000 a year?

In the field of Sterility Assurance, senior roles such as Director of Sterility Assurance or Quality Assurance Director can reach annual salaries of $300,000 or more, especially with extensive experience, advanced certifications, and leadership responsibilities. These positions often require strong knowledge of regulatory standards, risk management, and quality systems within the pharmaceutical or medical device industries.

What is the highest-paying job in pharmaceuticals?

In pharmaceuticals, senior roles such as Director of Quality Assurance or Sterility Assurance often have the highest salaries, especially for those with extensive experience and advanced certifications. These positions typically involve overseeing compliance, validation, and sterile manufacturing processes, and can command six-figure salaries depending on the company and location.

What jobs can you get with a sterile processing certification?

Sterility assurance certification qualifies individuals for roles such as sterile processing technician, surgical instrument technician, or sterilization technician. These jobs involve cleaning, sterilizing, and maintaining medical instruments in healthcare settings, often requiring knowledge of sterilization methods and use of sterilization equipment. Certification enhances employment prospects and may lead to supervisory or specialized positions in infection control and hospital support services.

What are the key skills and qualifications needed to thrive in the Sterility Assurance position, and why are they important?

To thrive in Sterility Assurance, you need a solid understanding of microbiology, aseptic techniques, and regulatory compliance, often supported by a degree in life sciences or a related field. Familiarity with sterilization validation methods, environmental monitoring systems, and quality management standards such as ISO and GMP is essential. Strong analytical thinking, problem-solving, and meticulous attention to detail set top performers apart in this role. These competencies are crucial to ensure product safety, regulatory compliance, and the prevention of contamination in pharmaceutical and medical device manufacturing environments.

What is sterility assurance job description?

A sterility assurance job involves ensuring that medical devices, pharmaceuticals, or other products are free from viable microorganisms through validation, monitoring, and quality control processes. Professionals in this field typically work with sterilization equipment, follow strict regulatory standards, and may hold certifications such as Certified Sterility Assurance Professional (CSAP). The role requires attention to detail, knowledge of sterilization methods, and adherence to safety protocols.
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What states have the most Sterility Assurance jobs? States with the most job openings for Sterility Assurance jobs include:
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Sterility Assurance jobs near you
Infographic showing various Sterility Assurance job openings in the United States as of July 2026, with employment types broken down into 93% Full Time, and 7% Part Time. Highlights an 100% In-person job distribution, with an average salary of $93,338 per year, or $44.9 per hour.
Sterility Assurance Lead

Sterility Assurance Lead

Kelly Services

Raleigh, NC • On-site

$90K - $110K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 14 days ago

Job description

The Sterility Assurance Lead is responsible for leading and maintaining site-wide sterility assurance and contamination control programs within a sterile pharmaceutical manufacturing environment. This role provides technical leadership and oversight for terminally sterilized and injectable drug product operations, ensuring compliance with FDA aseptic processing guidance, EU Annex 1, cGMP standards, and global regulatory requirements. The position serves as the site Subject Matter Expert (SME) for sterility assurance, environmental monitoring, microbiological risk management, and contamination control strategies while supporting process validation, regulatory inspections, and continuous improvement initiatives.
Location: Raleigh NC
Salary: $90,000-$110,000/year
Direct Hire role
No relocation assistance offered

Key Responsibilities Sterility Assurance & Contamination Control
  • Develop, implement, and maintain sterility assurance and contamination control programs for sterile manufacturing operations
  • Lead the site Contamination Control Strategy (CCS) and ensure alignment with regulatory expectations and industry best practices
  • Serve as SME for sterility assurance, microbiological oversight, and contamination control activities
  • Define and monitor microbiological and particulate alert/action limits
  • Ensure environmental monitoring programs are effectively designed, executed, evaluated, and maintained throughout the product lifecycle
  • Support inspection readiness and participate in regulatory inspections and audits as the sterility assurance SME
  • Prepare and support responses to regulatory observations related to sterility assurance and contamination control
Process Oversight, Validation & Qualification
  • Provide oversight for terminal sterilization and aseptic manufacturing processes across development, validation, and commercial operations
  • Review and approve critical manufacturing and sterilization activities including washing, filling, sterilization cycles, and environmental controls
  • Review and approve validation strategies, protocols, and reports including IQ/OQ/PQ activities
  • Ensure appropriate microbiological and particulate control strategies are established and maintained
  • Support ongoing process verification and continued process monitoring activities
Investigations, Risk Assessment & CAPA
  • Lead or support investigations involving microbiological deviations, contamination events, and sterility-related nonconformances
  • Conduct and review risk assessments related to sterility assurance and contamination control
  • Drive development and implementation of CAPAs to mitigate contamination and sterility risks
  • Monitor trends and recurring issues to identify and address systemic risks
Cross-Functional Collaboration & Training
  • Partner with Manufacturing, Engineering, Validation, Quality Control Microbiology, and Quality Assurance teams to ensure effective sterility assurance integration
  • Provide coaching, training, and guidance on contamination control principles, aseptic behaviors, and sterility assurance best practices
  • Support development and revision of SOPs, work instructions, and training materials
  • Promote a strong quality culture focused on compliance, contamination control, and operational excellence
Continuous Improvement & Operational Support
  • Participate in operational excellence and continuous improvement initiatives
  • Support technology transfers, new product introductions, and cross-functional projects
  • Assist with internal audits, gap assessments, and periodic reviews of sterility assurance systems
  • Support departmental and site objectives as assigned
Qualifications Education
  • Bachelor’s or Master’s degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific discipline
Experience
  • Minimum 5 years of experience in sterile pharmaceutical manufacturing, injectable products, or terminal sterilization environments
  • Experience supporting aseptic processing and/or terminal sterilization operations
  • Strong knowledge of microbiology principles, contamination control, and cleanroom manufacturing
  • Experience supporting validation, qualification, and regulatory compliance activities

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.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.

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