QA/RA Documentation Specialist Job Listing at Kelly Services in Earth City, MO (Job ID 10065528)

Description

Job Title: Quality Control Inspector – QA/RA Documentation Specialist
Location: [Insert Location]
Pay Rate: $20 – $22/hour (Up to $24/hour for highly qualified candidates)
Position Summary:
The QA/RA Documentation Specialist is responsible for supporting and maintaining compliance with U.S. and international Quality System requirements. This role focuses on establishing and optimizing Quality Management System (QMS) processes, transitioning paper-based documentation to digital systems, and managing quality control and regulatory documentation. The ideal candidate possesses strong attention to detail, organizational expertise, and effective written and verbal communication skills. This position reports directly to the Director of Quality and Regulatory Affairs and offers an exciting opportunity to make a significant impact in process improvement and compliance.
Key Responsibilities:

• Support document control functions, including change control management and maintaining records according to defined, categorized, and implemented document types.
• Drive the transition from paper-based to digital record-keeping systems, including scanning files and organizing digital file structures.
• Oversee and maintain filing systems, ensuring consistent and accessible record organization across the company.
• Collaborate with regulatory affairs to create documentation templates and provide relevant product documentation for submissions and registrations.
• Document and track nonconforming materials, including disposition and closure, ensuring timely resolution.
• Coordinate training documentation, retention, and management for compliance purposes.
• Sustain QMS activities through the completion of Standard Operating Procedures (SOPs) and Work Instructions.
• Collect, report, and analyze quality data; support resolution of material and product quality issues.
• Recommend, implement, and drive process improvements and continuous quality enhancement initiatives, working with cross-functional teams.
• Support site quality system activities for compliance with international regulations and standards (including 21 CFR 820, ISO 13485, EU MDR, and MDSAP).
• Conduct internal audits, document audit findings, and lead corrective and preventive actions to resolve nonconformance.
• Ensure document retention systems meet audit and regulatory requirements.

Supervisory Responsibilities:

• None.
• Reports directly to the Director, Quality and Regulatory Affairs.

Required Qualifications:

• 0–3 years experience in a regulated industry.
• Strong organizational skills, exceptional attention to detail.
• Excellent written and verbal communication skills.
• Experience in scanning, sorting, and creating organized filing structures.
• Proficient with Microsoft Office Suite (Word, Excel, PowerPoint, Access) and Adobe software.
• Legally authorized to work in the United States.

Desired Qualifications:

• Experience with electronic Quality Management Systems (eQMS).
• Knowledge of quality standards and regulations: ISO 13485, MDSAP, 21 CFR 820, EU MDR 2017/745.
• Experience with quality inspection processes and related equipment.
• Understanding of safety requirements and legal standards.

Key Competencies:

• Organization and structure
• Collaboration and teamwork
• QA process proficiency
• Computer literacy and technical aptitude
• Initiative in driving process improvement

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.

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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.

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