Quality Assurance Associate

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.