QA Specialist III

Job Description

Job Description

Aptask Global Workforce (AGW) is seeking a QA Specialist III – Audits & Inspections for an Onsite position with a Global Biotechnology Company located in Greenville, NC. This is a 12-month contract opportunity.

This role is responsible for executing and maintaining the Internal Audit, Client audit, and Regulatory inspection programs. The specialist will ensure the site complies with various guidelines including 21 CFR Parts 210/211, 600, 820, ISO 13485, ISO 9001, and ICH Q9 and Q10. This position supports quality compliance through the execution of audits and ensures readiness for regulatory agency reviews.

Responsibilities:

• Support scheduling, hosting, and responding to external client audits
• 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 data to identify systemic risks and drive continuous improvement
• Monitor deviations, audit Corrective and Preventive Actions (CAPAs), and health authority commitments, ensuring timely completion
• Ensure appropriate effectiveness checks are defined for assigned audit CAPAs
• Utilize effective communication channels to support the maintenance and improvement of the audits and inspections program
• Ensure critical documentation is appropriately documented and stored

Requirements:

• 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
• Excellent communication and interpersonal skills
• 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
• Detail-oriented with a keen eye for identifying process improvement opportunities
• Strong relationship-building skills with the ability to work effectively in team environments

Pay range: up to $45.00 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.