Quality Specialist III

Experis Austria; Greenville (NC); On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care FSA

Life Insurance

Short/Long Term Disability Insurance

Business Travel Insurance

401(k) with Match

Weekly Pay

Job summary

Our client in Greenville, NC is seeking a Quality Specialist III to join the Quality organization supporting audits and inspections. The role requires leading internal, client, and regulatory audit programs and ensuring inspection readiness with health authorities such as FDA, EMA, ANVISA, and MHRA.

The ideal candidate will have a Bachelor's in a scientific/engineering/health field, 5+ years in pharma/medical devices, and 8+ years in quality focusing on deviations and CAPAs, with strong

Qualifications

• Bachelor's degree in a scientific, engineering, or health-related field.
• At least 5 years of experience in the pharmaceutical or medical device industry.
• At least 8 years of experience in quality within the pharmaceutical or medical device industry focusing on deviation management, pharmaceutical operations, quality assurance, or related areas.
• Strong working knowledge of 21 CFR Part 210/211, 21 CFR Part 600, 21 CFR Part 820, ISO 13485, ISO 9001, and ICH Q9/Q10.
• Proficiency with electronic quality management systems (Documentum, Veeva Vault, TrackWise) and strong communication, organization, and problem-solving skills.

Responsibilities

• Execute and maintain internal, client, and regulatory audit programs to support quality compliance.
• Coordinate external audit preparations including scheduling, hosting, and responses to findings.
• Support inspection readiness with mock and actual regulatory inspections (FDA, EMA, ANVISA, MHRA).
• Track, trend, and analyze audit data and quality issues to identify systemic risks and drive improvement.
• Monitor deviations and CAPAs, ensuring timely responses and effectiveness checks.

Skills

Audit & inspections

Deviation management

Regulatory compliance

Quality systems

Cross-functional collaboration

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

We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability