Overview
Quality Assurance Specialist Jobs in Morrisville, NC at Harba Solutions Inc.
Title: Quality Assurance Specialist
Company: Harba Solutions Inc.
Location: Morrisville, NC
Position Summary:
We are seeking a detail-oriented and experienced Quality Assurance (QA) Specialist to support and drive quality initiatives across our operations. This individual will play a key role in ensuring compliance with internal quality standards and applicable regulatory requirements (e.g., FDA, ISO, GLP). The ideal candidate brings a strong background in quality systems, document control, audits, and continuous improvement within a Biotechnology environment.
Key Responsibilities:
Support internal and external audits, including FDA, ISO, and customer audits.
Author, review, and approve SOPs, work instructions, deviations, CAPAs, and change controls.
Ensure compliance with cGMP/cGLP/cGCP and applicable quality standards (e.g., ISO 13485, 21 CFR Part 11, Part 210/211).
Support validation activities, including equipment qualification and process validation documentation.
Perform root cause analysis and develop effective corrective and preventive actions.
Collaborate cross-functionally with Operations, Manufacturing, QC, R&D, and Regulatory teams.
Monitor quality metrics and drive initiatives for continuous quality improvement.
Maintain and improve document control and training systems.
Qualifications:
Bachelor’s degree in a life science, engineering, or related field (advanced degree a plus).
3-5 years of quality assurance experience in a regulated environment (biotech, pharma, medical device, etc.).
In-depth knowledge of quality systems and regulatory guidelines (e.g., FDA QSR, ISO 9001/13485, ICH Q10).
Experience with electronic quality management systems (eQMS) such as MasterControl, Veeva, TrackWise, etc.
Strong problem-solving skills with the ability to influence and drive change.
Excellent attention to detail, documentation, and communication skills.
