The Quality Assurance Specialist is responsible for the internal audit program, process/ equipment validation, and investigations. Specifically, this role will support the company’s Quality Management System, including internal audits, and investigations related to non-conformances, corrective actions, and complaints.
RESPONSIBILITIES & ESSENTIAL JOB FUNCTIONS
• Supports the Supplier Quality, SCAR, CAPA, Complaints investigations.
• Leads the Internal Audit process and participates in customer audits as required. Supports regulatory, ISO 9001 and ISO 13485 re-certification audits.
• Prioritizes and completes validation/re-validation activities for new and existing processes, materials, and equipment.
• Maintains Supplier approvals, including qualification surveys, in CRM system.
• Implements Statistical Process Control for high volume, high speed manufacturing processes.
• Ensures compliance with and/or follows all organizational systems, programs, training, policies, and procedures as required and complies with relevant legal mandates. Seeks guidance as necessary.
• Actively supports and participates in the safety program, both for self-protection and the protection of other employees, by reading and abiding by all requirements in the Safety Manual and Injury Illness Prevention Program (IIPP).
• Carries out all responsibilities in an honest, ethical and professional manner.
• Bachelor of Science Degree in Quality, Mechanical, or Industrial Engineering is preferred. Equivalent work experience and industrial certifications may be accepted in lieu of a college degree.
• 2+ years of experience within a GMP-regulated manufacturing environment is preferred.
• Hands-on experience with process and equipment validation is required.
• SPC implementation, CAPA and Complaint investigation, QMS auditing experience preferred.
• Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint) and Adobe Acrobat required.
• Excellent planning, organization, and negotiation skills.
• Ability to multi-task as necessary to meet business needs.
• Excellent verbal and written communication skills.
• Must be able to work in a team environment.
• Must be able to pay close attention to details.
• Must be able to adapt to a changing and dynamic environment with shifting priorities.