Job Information
Kelly Services QA External Quality Engineer (Sterile Products) in Bridgeton, Missouri
Job Title: Quality Engineer – External (Aseptic / Sterile Manufacturing)
Position Summary
This position is responsible for external Quality Assurance oversight, with a primary focus on sterile manufacturing and aseptic processing. The role ensures that CMOs, suppliers, and laboratories comply with FDA, EMA, and global cGMP requirements for sterile injectables.
This individual will play a critical role in supporting aseptic operations, regulatory inspections, and maintaining high standards of sterility assurance across external partners. Periodic domestic and international travel is expected; a valid passport is required
Key Responsibilities
GMP Compliance (Sterile CMOs/Suppliers)
Ensure compliance with FDA, EMA, and global cGMPs specific to aseptic processing and sterile injectables
Lead supplier qualification for sterile manufacturing sites
Perform and support audits focused on aseptic filling, cleanroom operations, and contamination control strategies
Maintain audit schedules and ensure inspection readiness
Monitor regulatory updates related to sterile manufacturing (e.g., Annex 1)
Support new product introductions involving sterile dosage forms
Expected Outcome:
Highly compliant sterile supplier network with strong inspection readiness
Quality Assurance Oversight
Review and approve deviations, EM excursions, OOS/OOT results, and change controls
Evaluate aseptic process performance and contamination control trends
Track and verify effectiveness of corrective actions from audits
Support management of Approved Supplier List (ASL)
Ensure compliance with sterility assurance elements including validation, media fills, and environmental monitoring
Expected Outcome:
Strong sterility assurance and minimized contamination risk
Quality Planning & Continuous Improvement
Support validation strategies (process validation, cleaning validation, aseptic media fills)
Drive continuous improvement in contamination control and aseptic practices
Collaborate with Regulatory, Clinical, and Quality Risk Management teams
Support inspection readiness and host regulatory inspections when needed
Present quality metrics and compliance risks to leadership
Expected Outcome:
Continuous improvement in sterile manufacturing compliance and audit outcomes
Qualifications
Bachelor’s degree in Biology, Chemistry, Engineering, or related field
Minimum 5+ years in pharmaceutical quality within sterile/aseptic manufacturing
Strong knowledge of aseptic processing, Annex 1, and sterile GMP requirements
Experience auditing sterile CMOs and supporting regulatory inspections
Hands-on experience with environmental monitoring, media fills, and contamination control
Key Skills
Deep expertise in aseptic processing and sterility assurance
Strong auditing and inspection readiness experience
Root cause analysis and risk management
Ability to work cross-functionally in a global environment
Strong communication and stakeholder management skills
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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.