Quality Lab Manager

Kelly Services; Eau Claire (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Telemedicine

Life insurance

Legal plan

Short-term disability

Retirement plan

Holiday pay

Job summary

Kelly Services is seeking a Quality Assurance Manager in Eau Claire, Wisconsin, to lead QA operations for infant formula products, ensuring compliance with FDA regulations and cGMP. The role collaborates with Manufacturing, Laboratory, Engineering, and Warehouse teams to safeguard product safety and regulatory readiness.

The position requires a Bachelor’s degree in a scientific field, 5+ years in a regulated environment, and strong leadership abilities with experience in QA systems, CAPA, and

Qualifications

• Bachelor’s degree in scientific, technical, food science, pharmaceutical science, or related field.
• At least five years of experience in a regulated manufacturing environment.
• Experience in infant formula, food, pharmaceutical, biotechnology, or related industry preferred.
• Previous leadership, supervisory, or management experience within a quality assurance function.
• Strong knowledge of cGMP requirements, FDA regulations, quality systems, investigations, CAPA, audits, and change control.
• Familiarity with FDA requirements under 21 CFR Parts 106 and 107 strongly preferred.
• Excellent written and verbal communication skills.
• Strong analytical, problem-solving, organizational, and decision-making abilities.
• Ability to manage multiple priorities and collaborate effectively across departments.

Responsibilities

• Oversee quality assurance activities related to infant formula manufacturing, including batch record review, product disposition and release, and quality systems management.
• Ensure compliance with applicable FDA regulations, including 21 CFR Parts 106 and 107, cGMP.
• Lead investigations into deviations, nonconformances, complaints, and other quality events.
• Conduct root-cause analyses and develop, implement, and monitor CAPA.
• Conduct internal audits and support FDA, customer, corporate, and other regulatory inspections and audits.
• Review and approve SOPs, change controls, validation and qualification documents, specifications, batch records, and other quality-critical documentation.
• Collaborate with cross-functional teams to resolve quality issues and improve product and process performance.
• Monitor key quality metrics and lead continuous improvement initiatives.
• Train, mentor, and supervise QA personnel while promoting a strong culture of quality and compliance.
• Serve as a key decision-maker for product quality, disposition, and release.
• Ensure QA records are accurate, complete, timely, and maintained in accordance with company procedures and regulatory requirements.
• Promote a proactive approach to risk management, process control, and ongoing regulatory readiness.

Skills

Leadership

Regulatory compliance

Quality systems

Root-cause analysis

CAPA management

Auditing

Cross-functional collaboration

Education

Bachelor’s degree in scientific, technical, food science, pharmaceutical science, or related field

Job description

Quality Assurance Manager- Eau Claire, Wisconsin

The Quality Assurance Manager is responsible for ensuring that all infant formula products are manufactured, tested, stored, and released in full compliance with applicable FDA regulations, cGMP requirements, and company quality standards. This position leads daily QA operations and partners closely with Manufacturing, Laboratory, Engineering, Warehouse, and other cross-functional teams to maintain product safety, quality, compliance, and regulatory readiness.

Key Responsibilities

• Oversee quality assurance activities related to infant formula manufacturing, including batch record review, product disposition and release, and quality systems management.
• Ensure compliance with applicable FDA regulations, including 21 CFR Parts 106 and 107 , cGMP.
• Lead investigations into deviations, nonconformances, complaints, and other quality events.
• Conduct root-cause analyses and develop, implement, and monitor CAPA.
• Conduct internal audits and support FDA, customer, corporate, and other regulatory inspections and audits.
• Review and approve SOPs, change controls, validation and qualification documents, specifications, batch records, and other quality-critical documentation.
• Collaborate with cross-functional teams to resolve quality issues and improve product and process performance.
• Monitor key quality metrics and lead continuous improvement initiatives.
• Train, mentor, and supervise QA personnel while promoting a strong culture of quality and compliance.
• Serve as a key decision-maker for product quality, disposition, and release.
• Ensure QA records are accurate, complete, timely, and maintained in accordance with company procedures and regulatory requirements.
• Promote a proactive approach to risk management, process control, and ongoing regulatory readiness.

Required Qualifications

• Bachelor’s degree in scientific, technical, food science, pharmaceutical science, or related field.
• At least five years of experience in a regulated manufacturing environment.
• Experience in infant formula, food, pharmaceutical, biotechnology, or a related industry preferred.
• Previous leadership, supervisory, or management experience within a quality assurance function.
• Strong knowledge of cGMP requirements, FDA regulations, quality systems, investigations, CAPA, audits, and change control.
• Familiarity with FDA requirements under 21 CFR Parts 106 and 107 strongly preferred.
• Excellent written and verbal communication skills.
• Strong analytical, problem-solving, organizational, and decision-making abilities.
• Ability to manage multiple priorities and collaborate effectively across departments.

Preferred Leadership Competencies

• Demonstrated ability to build and maintain a strong quality culture.
• Sound judgment when making product-quality and release decisions.
• Ability to coach, develop, and motivate QA staff.
• Proven record of driving process improvements and resolving complex quality issues.
• Strong attention to detail and commitment to product safety and regulatory compliance.

#P1

Benefits & Perks

• 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.
• retirement savings plan
• service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• transit spending account
• paid sick leave under the applicable state or local plan

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 (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en)

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.