This function is responsible for scanning of finished product controlled documents and disposition and tracking of raw materials.  Functions include document scanning of completed finished product controlled documents to a sharepoint, review, TrackWise reporting, hold form review, discrepancy tracking, status reporting, resolution and escalation of raw material delays and maintenance of raw material issues log. 

The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations.  Works on problems of a diverse scope where analysis and problem solving is required.  Receives general oversight and guidance on approaches to complete related tasks.  Applies job related skills and understanding of policies and standards in completing tasks.

Key Duties:

• Scanning finished product controlled documents
• Evaluation of raw material records requiring certificate check and verification
• Disposition of raw materials and bulk batches per associated specifications.
• Interact with plant personnel to insure CGMP compliance.
• Provides back up for other QA and plant site personnel as appropriate.
• The monitoring of compliance with the requirement of GMP
• Ability to excel in a team environment

Preferred Skills/ Abilities:

• Working knowledge of US Drug Product GMP requirements and associated guidelines
• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
• Ability to increase others knowledge of US end European GMP regulations and guidance
• Strong written and oral communication skills
• Experience in administration of quality systems for drug product manufacturing and quality control operations

Preferred Personal Attributes:

• Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks
• Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others
• Good computer skills
• Good work ethic, dependable, punctual, and flexible
• Good motivator of personnel
• Good team player with a can-do attitude
• Can get things done on the basis of influence
• Can work in a fast-paced environment with multiple issues open simultaneously
• Highly organized
• Attention to detail
• Identifies opportunities to improve and contributes to problem solving

Required Education/ Experience:

• Bachelor’s degree in a scientific discipline or equivalent
• 2+ years relevant experience in a Quality Assurance role in the pharmaceutical industry, or equivalent 
• Working knowledge of US Drug Product GMP requirements and associated guidelines