Quality Assurance Analyst

Job Description: Requirement/Must Have: Minimum of 2 years of experience in a highly regulated industry. Strong knowledge of Quality Management Systems and compliance processes. Experience with deviation, CAPA, and change control processes. Strong communication, teamwork, problem-solving, and decision-making skills. bility to perform root cause analysis. bility to work in a team-based environment with minimal supervision. Experience: Experience in quality and compliance within Medical Device, Pharmaceutical, or Consumer Products industries preferred. Experience in distribution center operations preferred. Experience with Warehouse Management Systems and SAP preferred. Experience with Quality Management Systems tools preferred. Experience with temperature control and monitoring preferred. Experience supporting audits and regulatory inspections. Experience developing and reviewing SOPs and work instructions. Experience performing gap assessments against global and regulatory standards. Experience supporting new product launch activities in a distribution environment. Responsibilities: Oversee quality and compliance activities for product receiving processes, including inspection and system transactions. Monitor and manage quarantine, hold, stop-ship, and recall processes. Manage product refusals, inspection, and disposition activities. Serve as a point of contact for distribution quality-related matters and coordinate with internal and external partners. Ensure adherence to deviation, CAPA, change control, records management, and training processes. Support internal and external audits. Provide quality and compliance oversight for protocol execution. Escalate critical quality issues to management in a timely manner. Provide data, metrics, and reports for Quality System Management Reviews. Develop and review SOPs, work instructions, and related documentation. Identify and lead continuous improvement initiatives related to quality, cost, and efficiency. Perform compliance risk assessments and recommend corrective actions. Oversee clinical supply chain compliance activities, including labeling and re-pack/re-label processes. Monitor and review temperature data for the distribution center and related areas. Provide training to new hires and contractors. Support new product launch activities, including master data setup. Ensure compliance with local, state, federal, and international regulations. Support 24/7 distribution center operations as needed. Should Have: Proficiency in organizational and project management skills. Experience with temperature-controlled supply chain environments. Experience in compliance risk evaluation and corrective action tracking. Skills: Strong analytical and problem-solving skills. Effective verbal and written communication. Cross-functional collaboration. ttention to detail and compliance focus. bility to manage multiple priorities. Qualification and Education: Bachelor's degree in Engineering, Life Sciences, Technical Scientific discipline, or related field preferred. Relevant related experience may be considered in lieu of a degree.

Created: 2026-03-04