Quality Compliance Specialist

Kelly Services; Clearwater (FL); Presencial; USD 45.000 - 48.000; Jornada completa

Descripción de la vacante

Kelly Science & Clinical is seeking a Quality Compliance Specialist in Clearwater, FL for an on-site role. The position focuses on coordinating inspections, CAPA processes, and regulatory actions within a GMP facility.

Ideal candidates have a life sciences or engineering degree, 3+ years GMP experience, and strong analytical and problem-solving abilities. Proficiency in MS Office and excellent communication are required for documentation and teamwork.

Formación

• Education: Preferred Bachelor’s degree Life Sciences, Interdisciplinary Science, or Engineering.
• Experience: Minimum of 3 years in a GMP facility.
• Must have experience in medical device industry and CAPA experience.
• Independent and efficient work capabilities.
• Strong organizational and investigational skills.
• Ability to follow detailed procedures and multitask.
• Excellent analytical, problem-solving, and interpersonal skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Exceptional written and verbal communication skills.

Responsabilidades

• Inspection Coordination: prepare and execute inspections by regulatory agencies, consultants, and third parties.
• Organize CAPA Review Board and Quarterly Management Review meetings.
• Regulatory Compliance Assessment: identify improvement projects or CAPA.
• Regulatory Action Support: assist with market actions and field alerts.
• Record Maintenance: keep records of inspections, audits, CAPAs with root cause analysis.
• Quality Indicator Reviews: provide reviews and recommend changes to specs.
• Quality Change Requests: coordinate temporary and permanent quality changes.
• Internal Audits: participate in internal audits.
• Administrative Support: assist Quality Department with tasks.

Conocimientos

GMP experience

CAPA experience

Analytical thinking

Organizational skills

Educación

Bachelor’s degree Life Sciences, Interdisciplinary Science, or Engineering

Herramientas

Microsoft Office

Descripción del empleo

Quality Compliance Specialist

Kelly® Science & Clinical is seeking a Quality Compliance Specialist for our client, a leader in the medical device industry, in Clearwater, Florida. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Schedule : On-site Monday through Friday 8am to 5pm

Length of assignment: until end of 2027

Pay : $33-35 an hour

Roles and Responsibilities

• Inspection Coordination: Prepare and execute inspections by regulatory agencies, consultants, and third parties.
• O rganize CAPA Review Board meetings and Quarterly Management Review meetings.
• Regulatory Compliance Assessment: Identify improvement projects or CAPA through continuous assessment of the compliance environment.
• Regulatory Action Support: Assist with market actions, field alert reports, and other regulatory activities.
• Record Maintenance: Maintain thorough records of inspections, audits, and CAPAs, including root cause analysis and effectiveness checks.
• Quality Indicator Reviews: Provide documented reviews and recommend changes in product or process specifications.
• Quality Change Requests: Coordinate both temporary and permanent quality change requests.
• Internal Audits: Participate actively in internal audits.
• Administrative Support: Assist the Quality Department with various administrative tasks.

Qualifications & Skills

• Education: Preferred Bachelor’s degree Life Sciences, Interdisciplinary Science, or Engineering.
• Experience: Minimum of 3 years in a GMP facility.
• MUST have experience in medical device industry and CAPA experience
• Independent and efficient work capabilities.
• Strong organizational and investigational skills.
• Ability to follow detailed procedures and multitask.
• Excellent analytical, problem-solving, and interpersonal skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Exceptional written and verbal communication 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. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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. 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 (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 Affiliated Anti-Discrimination 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.