Quality Specialist III
$45 per hourExperis
Our client, Quality & Compliance in the pharmaceutical and medical device space is seeking a Quality Specialist III to join their team. As a Quality Specialist III, you will be part of the Quality organization supporting Audits & Inspections. The ideal candidate will bring a strong commitment to quality, the ability to collaborate cross-functionally, and the drive to stay inspection-ready through disciplined execution and continuous improvement.
Job Title: Quality Specialist III
Location: Greenville, NC
Pay Range: $45/hr
Duration: 12 months
What's the Job?
- Support the Internal Audit, Client audit, and Regulatory inspection programs by executing audit activities and maintaining inspection readiness.
- Prepare for, schedule, host, and respond to external client audits while ensuring documentation and responses align with applicable quality requirements.
- Support mock inspections and actual regulatory inspections with health authority agencies such as FDA, EMA, ANVISA, and MHRA.
- Monitor the Audits & Inspections program by tracking, trending, and analyzing audit/inspection outcomes and quality issues to identify systemic risks and drive continuous improvement.
- Support deviation and CAPA management by monitoring audit-related deviations, CAPAs, and health authority commitments to ensure timely completion and submission; ensure appropriate effectiveness checks are defined for assigned audit CAPAs.
What's Needed?
- Bachelor's degree in a scientific, engineering, or health-related field.
- At least 5 years of experience working within the pharmaceutical or medical device industry.
- At least 8 years of experience working in quality within the pharmaceutical or medical device industry, including deviation management, pharmaceutical operations, quality assurance, or relevant business areas.
- Strong working knowledge of 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10.
- Proficiency with electronic quality management systems such as Documentum, Veeva Vault, and TrackWise, along with strong communication, organization, and problem-solving skills.
What's in it for me?
- Opportunity to strengthen quality compliance by ensuring audit and inspection readiness across internal, client, and regulatory activities.
- Chance to contribute to continuous improvement by analyzing trends, identifying systemic risks, and supporting corrective actions.
- Role that emphasizes cross-functional collaboration through mock inspections, coaching subject matter experts, and clear communications.
- Responsibility for governance through KPI reporting to senior leadership related to audits and inspections.
- Experience working with established quality frameworks and documentation practices that support regulatory expectations.
Upon completion of waiting period consultants are eligible for:
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account
- Health Flexible Spending Account
- Dependent Care Flexible Spending Account
- Supplemental Life Insurance
- Short Term and Long Term Disability Insurance
- Business Travel Insurance
- 401(k), Plus Match
- Weekly Pay
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells –creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.
Schedule: Workers must report to site M-F standard business hours. No remote work.
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