Quality Assurance Specialist

Job Summary

To support external manufacturing operations, the full-time Quality Assurance Specialist will oversee compliance with regulatory requirements and industry standards while managing product quality complaints and collaborating with internal and external teams.

Key responsibilities

• Act as QA Initiator and Investigator for Product Quality Complaints, ensuring timely initiation and compliance
• Serve as the primary contact for internal teams and external manufacturing partners, managing inquiries and fostering collaboration
• Support the development and execution of CAPAs, change controls, and validation documentation related to GMP activities

Required qualifications

• Associate's degree or equivalent work and education in a related field; BA preferred
• 2+ years of experience in the pharmaceutical or related industry, preferably in quality assurance or compliance
• Basic knowledge of relevant regulations, CAPAs, and change control processes
• Proficient in Microsoft Office software products, including Outlook, Word, Excel, and PowerPoint
• Experience working autonomously with proven ability to meet deadlines