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 Stim Labs 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 Master Control and Infor system questions or concerns.
• Other tasks and projects, as assigned by department leadership.

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.