Quality Specialist III

VARITE INC; Greenville (NC); On-site; USD 58,000 - 62,000; Full time

Benefits offered by this job

Health Insurance

Retirement Plans

Legal Service Plans

Job summary

VARITE INC is seeking a Quality Specialist III in Greenville, NC for a 12-month onsite role. The position focuses on audits, inspections, and regulatory compliance under 21 CFR and related standards.

You will coordinate external client audits, readiness activities, and CAPA governance within a fast-paced life science environment. Requirements include a Bachelor's in a scientific/engineering/health field and 5+ years in pharma/medical device quality, with 8 years in related quality roles.

Qualifications

• Bachelor's degree in a scientific, engineering, or health-related field.
• At least 5 years of experience in pharmaceutical or medical device industry.
• At least 8 years of quality experience in deviation management, pharmaceutical operations, quality assurance, or related areas within pharma/healthcare.

Responsibilities

• External Audit Preparation & Execution: support scheduling, hosting, and responding to external client audits.
• Inspection Readiness & Execution: support mock inspections and actual regulatory inspections with agencies such as FDA, EMA, ANVISA, MHRA.
• Governance (Metrics & Monitoring): track, trend, and analyze audit/inspection data to identify risks and drive improvement; report KPIs to leadership.
• Deviation & CAPA Management: monitor deviations and CAPAs; ensure timely responses and actions.
• Effectiveness Checks: define and validate effectiveness for audit CAPAs to prevent recurrence.
• Communications: use effective channels to ensure awareness and participation in audits and inspections.
• Documentation & Record retention: ensure critical documents are stored to support audits and inspections.

Skills

CFR Part 210/211

CFR Part 600

QMSR

ISO 13485

ISO 9001

ICH Q9 Q10

Communication

Cross-functional

Problem solving

TrackWise familiarity

Documentum familiarity

Veeva Vault familiarity

Education

Bachelor's degree in science/engineering/health

Tools

Documentum

Veeva Vault

TrackWise

Job description

VARITE is looking for qualified Quality Specialist III in Greenville, NC 27834 (Onsite)

WHAT THE CLIENT DOES?

An American-headquartered life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.

WHAT WE DO?

Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

Job Title:Quality Specialist III

Location: Greenville, NC 27834 (Onsite)

Contract Duration: 12 months with possible extension

Pay Range: $42.00/hr. to $45.00/hr. on W2

HERE’S WHAT YOU’LL DO

Job Description:

• A Quality Specialist III - Audits & Inspections is responsible for executing and maintaining the Internal Audit, Client audit and Regulatory inspection programs.
• The Quality Specialist III ensures the site complies to the following guidelines: 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.
• The Quality Specialist III supports quality compliance through the execution of internal and external audits and ensures inspection readiness for regulatory agency reviews.
• The Quality Specialist III supports cross-functional audits and inspection readiness by coordinating mock inspections and coaching subject matter experts.

Key Responsibilities:

• External Audit Preparation & Execution: Support scheduling, hosting, and responding to external client audits.
• Inspection Readiness & Execution: Support mock inspections and actual regulatory inspections with health authority agencies such as FDA, EMA, ANVISA, and MHRA.
• Governance (Metrics & Monitoring): Support monitoring the Audits & Inspections program by tracking, trending, and analyzing data from past audits, inspections, and quality issues to identify systemic risks and drive continuous improvement. Reporting key performance indicators (KPIs) related to audits and inspections and continuously informing senior leadership.
• Deviation & CAPA Management: Monitor deviations, audit Corrective and Preventive Actions (CAPAs), and health authority commitments ensuring responses and actions are completed and submitted on time.
• Effectiveness Checks: Ensure appropriate effectiveness checks are defined and appropriate for assigned audit CAPAs to identify the success of elimination of root causes and prevention of new occurrences
• Communications: Utilize effective communication channels, tools, and resources to ensure appropriate awareness and participation to support the maintenance and continuous improvement of the audits and inspections program.
• Documentation & Record retention: Ensure critical documentation is appropriately documented and stored to support client audits and regulatory inspections.

Minimal Requirements:

• Education: Bachelor's degree in a scientific, engineering, or health-related field.
• Experience: At least 5 years of experience working within the pharmaceutical or medical device industry
• Experience: 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 within the pharmaceutical or healthcare industry.

Skills:

• 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
• Excellent communication and interpersonal skills with the ability to collaborate cross-functionally and communicate complex quality concepts to stakeholders at all levels
• Strong problem-solving skills with a proven track record in issue resolution
• Proficient in electronic quality management systems such as Documentum, Veeva Vault, and TrackWise
• Strong organizational and time management skills to meet critical business and functional timelines
• Detail oriented with keen eye for identifying process improvement opportunities
• Strong relationship-building skills with the ability to work effectively in team environments across all organizational levels

BENEFITS:

We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan.
• Legal Service Plans: Offering access to attorneys for legal advice and representation.

VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.