This role is responsible for supporting the daily activities related to manufacturing operations and quality systems.  Once fully trained, this position is eligible for work from home up to 1 day per week.

Key Duties:

• Issuance of GxP documentation.
• Document Management System Support.
• Support documentation lifecycle (Document Scanning, Verification, Retention, and Destruction).
• Develop Standard Operating Procedures and other quality related documents.
• Evaluation of executed documentation (logbooks, controlled forms, and other documentation).
• Support area initiatives and projects.

Skills / Abilities:

• 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 support of quality systems for drug product manufacturing and quality control operations.
• Working knowledge of US Drug Product GMP requirements and associated guidelines.

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.

 Education:

• Requires a Bachelor’s degree in a scientific discipline or equivalent experience.

 Experience:

• 0-2 years’ experience in a Quality Assurance role in the pharmaceutical industry.

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