Overview
Responsible for developing, maintaining, and complying with American Injectables quality assurance standards.
Responsibilities:
Provide QA support to develop specifications for raw materials, components, intermediate products, and Finished
Drug Product.
Plan, execute, and oversee sampling/inspection and testing of product to confirm quality and conformance to
specifications and test methods for raw materials, components, intermediate products, and Finished Product.
Provide QA support during investigations efforts on quality events, including investigation technical writing.
Provide QA Support during APIs and Finished Product Retains inspections.
Identify and implement quality continuous improvement processes (both internally and externally) which
increase efficiency and maintain high quality standards.
Review batch records, manufacturing procedures, laboratory raw data and other quality-related documents for
accuracy and compliance with established standards.
Provide quality assurance GMP oversight to manufacturing, QC testing and batch release.
Provides visibility to cross-functional team to qualify, transfer and implement changes.
Ensure systems are in compliance with current SOPs.
Interact with multiple business functional areas (e.g., Quality Control, Operations, Facilities, etc.), ensuring GMP
quality compliance and best practices are met.
Report quality issues to ensure resolution in accordance with company guidelines and external regulatory
requirements
May perform additional duties as required.
Qualifications:
Required:
Education and Experience :
• Associates of Science in technical or scientific discipline required, or 3 years related experience in lieu of
degree. Bachelor of Science desired.
• 3-5 years of quality and/or manufacturing experience in a pharmaceutical or biotech environment.
• Expertise in U.S. and international GMPs. Must understand standards of practice for GMP training.
• Previous experience in quality assurance or a similar field.
• Working knowledge of tools, methods, and concepts of quality assurance.
• Solid knowledge of relevant regulatory standards.
• Good communication skills, both verbal and written.
• Excellent data collection and analysis skills.
• Strong attention to detail.
• Committed to the concept of team and working within the framework of the American Injectables
organization
• Proficiency with Microsoft Suite (Word, PowerPoint, and Excel)
Physical Requirements:
Employee may be required to lift or handle objects not more than 50 pounds to perform certain duties essential
to the job function.
Performance of tasks essential to the job function may require the employee to work directly with, handle, or
otherwise come into contact with chemicals or pharmaceutical agents.
Training:
Must successfully complete all departmental training modules and meet the requirements as part of ongoing
training.
Must successfully complete all material handling training/verification as part of ongoing training.