Quality Assurance Specialist Position Available In Wake, North Carolina
Tallo's Job Summary: A Quality Assurance Specialist position is available for a detail-oriented individual with 3-5 years of experience in a regulated environment. Responsibilities include supporting audits, ensuring compliance with quality standards, and driving continuous improvement initiatives. The ideal candidate holds a Bachelor's degree in a related field and possesses strong problem-solving skills and knowledge of regulatory guidelines.
Job Description
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.
