Job Details

Job DescriptionJob DescriptionAptask Global Workforce (AGW) is seeking a QA Specialist III – Audits & Inspections for a 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 to ensure site compliance with cGMP, ISO, and other industry guidelines. The ideal candidate will support quality compliance through internal and external audits, ensure inspection readiness, and manage related deviations and CAPAs within the pharmaceutical and medical device sector.Key Responsibilities:Support scheduling, hosting, and responding to external client auditsSupport mock inspections and actual regulatory inspections with health authority agencies such as FDA, EMA, ANVISA, and MHRASupport 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 improvementMonitor deviations, audit Corrective and Preventive Actions (CAPAs), and health authority commitments ensuring responses and actions are completed and submitted on timeEnsure appropriate effectiveness checks are defined and appropriate for assigned audit CAPAs to identify the success of elimination of root causes and prevention of new occurrencesUtilize effective communication channels, tools, and resources to ensure appropriate awareness and participation to support the maintenance and continuous improvement of the audits and inspections programEnsure critical documentation is appropriately documented and stored to support client audits and regulatory inspectionsRequirements:Bachelor's degree in a scientific, engineering, or health-related fieldAt least 5 years of experience working within the pharmaceutical or medical device industryAt 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 areasStrong 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 Q10Excellent communication and interpersonal skills with the ability to collaborate cross-functionallyStrong problem-solving skills with a proven track record in issue resolutionProficient in electronic quality management systems such as Documentum, Veeva Vault, and TrackWiseStrong organizational and time management skills to meet critical business and functional timelinesDetail oriented with keen eye for identifying process improvement opportunitiesStrong relationship-building skills with the ability to work effectively in team environments across all organizational levelsPay range: up to $45.00 per hourOnly 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:MedicalDentalVisionSick 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 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.