Quality Compliance Specialist
Kelly Science, Engineering, Technology & Telecom · Clearwater, FL · 5 days ago
Science$33–$35/hrFull-time
About the role
Kelly® Science & Clinical is seeking a Quality Compliance Specialist for our client, a leader in the medical device industry, in Clearwater, Florida.
Schedule
- On-site Monday through Friday 8am to 5pm
- Length of assignment: until end of 2027
Pay
- $33-35 an hour
Responsibilities
- Inspection Coordination: Prepare and execute inspections by regulatory agencies, consultants, and third parties.
- Organize 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.
Benefits
- 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 applicable state or local plan