Quality Specialist III

ManpowerGroup

Greenville (NC)

On-site

USD 52,000 - 72,000

Full time

8 days ago
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Benefits offered by this job

Medical and Prescription Drug Plans
Dental Plan
Vision Plan
401(k) Plus Match
Weekly Pay

Job summary

ManpowerGroup is seeking a Quality Specialist III for a leading pharmaceutical and medical device organization in Greenville, NC. The role focuses on audits, inspections, and regulatory readiness to ensure quality compliance across programs.

The ideal candidate has strong collaboration skills, deep QA experience in pharma/medical devices, and hands-on expertise with 21 CFR, ICH Q9/Q10, and QMS systems like Documentum, Veeva Vault, TrackWise.

Qualifications

  • Bachelor's degree in a scientific, engineering, or health-related field.
  • 5+ years in pharma/medical device quality.
  • 8+ years in quality with deviation mgmt, GMP/QA, or related areas.
  • Knowledge of 21 CFR Part 210/211, Part 600, Part 820 QMSR, ISO 13485, ISO 9001, ICH Q9/Q10.
  • Experience with electronic QMS systems: Documentum, Veeva Vault, TrackWise.

Responsibilities

  • Execute and maintain internal, client audits and regulatory inspections programs.
  • Coordinate external audit preparation, scheduling, hosting, and timely responses to findings.
  • Support inspection readiness with mock and regulatory inspections by health authorities (FDA, EMA, ANVISA, MHRA).
  • Track, trend, and analyze audit data and quality issues to drive improvements.
  • Monitor deviations and CAPAs, ensure timely responses and effectiveness checks.

Skills

Audits & Inspections
Cross-functional Collaboration
Documentation & QA
Communication
Problem Solving

Education

Bachelor's degree in science/engineering/health

Tools

Documentum
Veeva Vault
TrackWise

Job description

Our client, a leading pharmaceutical and medical device organization is seeking a Quality Specialist to join their team. As a Quality Specialist III, you will be part of the Quality organization supporting Audits & Inspections. The ideal candidate will have strong attention to detail, the ability to collaborate cross-functionally, and a commitment to continuous improvement—skills that will align successfully in the organization.

Job Title: Quality Specialist

Location: Greenville, NC

Pay Range: $45

What's the Job?
  • Execute and maintain the Internal Audit, Client audit, and Regulatory inspection programs to support quality compliance.

  • Support external audit preparation by coordinating scheduling, hosting, and timely responses to client audit findings.

  • Drive inspection readiness by supporting mock inspections and actual regulatory inspections with health authority agencies such as FDA, EMA, ANVISA, and MHRA.

  • Support governance by tracking, trending, and analyzing audit/inspection data and quality issues to identify systemic risks and drive continuous improvement.

  • Monitor deviations and CAPAs, including health authority commitments, ensuring responses and actions are completed and submitted on time; perform effectiveness checks 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 in 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 in electronic quality management systems such as Documentum, Veeva Vault, and TrackWise, along with strong communication, organizational, and problem-solving skills.

What's in it for me?
  • Opportunity to strengthen inspection readiness and support regulatory success through structured audits and mock inspections.

  • Clear impact on quality outcomes by monitoring deviations, CAPAs, and health authority commitments.

  • Visibility with senior leadership through KPI reporting and ongoing program performance updates.

  • Hands‑on collaboration across teams to coach subject matter experts and coordinate cross‑functional audit activities.

  • Professional growth through continuous improvement focused on systemic risk identification and effectiveness verification.

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

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.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.

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