QA Project Specialist

Job Description

QA Project Specialist

SUMMARY

Provides Quality Assurance related project leadership as it relates to planning and execution of customer projects. Responsible for the collaboration, review, and approval of GMP documents needed for project execution. Represents the highest level of GMP understanding and accomplishment. Responsible for providing strong Quality leadership and scientific/GMP information support as the Quality representative for new products/projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Represents QA for all Quality related customer interactions. Responsible for clear, direct, and appropriate communication in customer interactions
• Provides process support during clinical development and or commercial activities. Including process validation as needed
• Collaborate, review, and approve all product related Change Controls, Master Batch Records, and Cleaning Documents
• Liaison between QA and other Company departments for Review and Approval of all required change controls for products they are representing
• Facilitates review and approval of documents with other QA Specialists if needed
• Assures that manufacturing processes, packaging, and testing comply with all regulatory filings and Company SOPs to ensure favorable quality inspections and customer satisfaction
• Serves as Q Liaison to the Technical Department and on Product/Project Implementation Teams
• Supports the Implementation of new processes and new business opportunities proposed for implementation into development and/or manufacturing

EDUCATION and/or EXPERIENCE

Bachelor’s degree in science or 5 years of Quality Assurance experience within the Pharmaceutical Industry; or a combination of Pharmaceutical Industry and Academic experience. Project Management experience, although not required, is beneficial to this position.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• Excellent customer service skills
• Knowledge of cGMP, cGLP, and FDA regulations, as well as internal quality related procedures
• Practical and theoretical knowledge of the basic principle of validation and their applications
• Analytical ability and ability to influence
• Excellent verbal, presentation, and written communication skills
• Ability to provide leadership in all aspects of QA/development processes
• Analytical skills with the ability to function in an interactive interdisciplinary team environment
• Proactive approach to problem solving and resolution