Specialist I, Quality Assurance

Job Description

• Performs the following duties with minimal supervision.
• Ensure minor non-conformances are fully investigated and effective corrective/preventive actions (CAPA) are implemented in a timely manner.
• Support change management processes including formal change controls.
• Review and approve controlled documents including standard operating procedures, work instructions, etc.
• Support site inspections, as needed.
• Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines.
• Enhance skills via regular training and continuing education, including professional society membership/participation.
• Perform other duties as required.

• Minimum of a Bachelor’s degree in related field and/or equivalent experience.
• Minimum of 1 year of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
• Working knowledge of quality systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
• General knowledge of aseptic manufacturing processes.

• Excellent organizational skills, attention to detail, and Good Documentation Practices.
• Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
• Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
• Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.