Quality Assurance Analyst

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.
• Ability to perform root cause analysis.
• Ability to work in a team-based environment with minimal supervision.

• 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.

• 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.

• Proficiency in organizational and project management skills.
• Experience with temperature-controlled supply chain environments.
• Experience in compliance risk evaluation and corrective action tracking.

• Strong analytical and problem-solving skills.
• Effective verbal and written communication.
• Cross-functional collaboration.
• Attention to detail and compliance focus.
• Ability to manage multiple priorities.

• 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.