Senior Quality Assurance Specialist

Essential Duties and Responsibilities Administer and maintain core quality system elements including Corrective and Preventive Action (CAPA), Deviations, Investigations, Nonconformances, Customer Complaints, Training Program Administration, Document Control and Record Management. Lead and perform root cause investigations, trend analysis, and effectiveness checks to ensure Customer Complaints, CAPA and Nonconformance activities are completed thoroughly and on time. Review and approve quality system documentation to ensure compliance with internal procedures and regulatory expectations. Support complaint handling activities, including investigation coordination, risk evaluation, and regulatory reporting. Monitor and report QMS metrics and performance indicators to management for Management Review and continuous improvement initiatives. Provide quality oversight during internal audits, supplier audits, and regulatory inspections; support preparation and responses to audit findings. Serve as a subject matter expert (SME) for QMS processes and provide training for other departments on quality system requirements. Drive continuous improvement initiatives to enhance QMS effectiveness, compliance, and efficiency. Support the onboarding process of new employees and ensure all quality requirements are met. Provide mentorship, training, and technical guidance to junior QA staff. Lead continuous improvement initiatives to strengthen QMS processes and promote a culture of quality. Team lead to act as the point person for coordinating workflow, serve as the primary point of contact for outliers, act as decision maker, identify/report gaps and pain points, and identify solutions to problems preventing growth and scale of the department. Liaison/Cross-function between multiple departments within the company including but not limited to: Quality and Regulatory Sector, Operations, Partner Alliance, Legal, Human Resources, Marketing, and Information Technology. Member of StimLabs Internal Audit Team. Participates in daily operations of the Quality department including but not limited to: General administrative tasks such as scheduling, filing, organizing etc. as needed. Assists with records management and the Document Control system, when necessary. Lead or collaborate when applicable, on development of Standard Operating Procedures, Work Instructions, and Forms. Daily management of Deviations, Investigations, CAPAs, Nonconformances, and Complaints. Lead or support Change Control activities where applicable. Collaborates with Operations to complete investigations and documentation. Assists all departments with investigations and documentation of CAPAs, Deviations, Nonconformance Reports, and Complaints, as directed by Quality Management. Support inspections and audits from regulatory agencies, as needed. Assists in training employees on new tasks/functions when designated by Quality Management. Assist all departments with MasterControl and Infor system questions or concerns. Other tasks and projects, as assigned by department leadership. Minimum Qualifications (Knowledge, Skills, and Abilities) Bachelor’s degree in a technical field, with at least three to five (3-5) years of Quality Assurance and/or Quality Control experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience. #J-18808-Ljbffr