Quality Assurance Associate: Training
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Scope of Function:
Primarily responsible for ensuring compliance as set forth by regulatory agencies; overseeing the internal training program and providing QA oversight for product manufacturing campaigns.
Reports to: Manager, Quality Assurance
Specific Duties:
Education, Experience and Skills Required:
Education:
Primarily responsible for ensuring compliance as set forth by regulatory agencies; overseeing the internal training program and providing QA oversight for product manufacturing campaigns.
Reports to: Manager, Quality Assurance
Specific Duties:
- Lead the development and management of a comprehensive compliance training program
- Enhance training courses to raise quality awareness and improve quality culture across all Operating Units
- Coordinate and track training to ensure compliance
- Evaluate and implement new and innovative training approaches and other technologies that may be used to deliver training
- Oversee the product manufacturing campaigns
- Perform reviews for executed Batch Production Records of product intermediates and final product
- Oversee Incident Notification program
- Track and provide feedback on exception documents
- Assist with technical and compliance issues
- Develop, write, and revise cGMP documents
- Participate in internal compliance audits
- Assist the Head of Department with projects
Education, Experience and Skills Required:
Education:
- Bachelor’s degree in Life Sciences or a related scientific field
- At least 3-5 years experience as a trainer
- Prior experience in a FDA regulated environment such as pharmaceutical or biologics industry is highly desirable
- Must be detail oriented with demonstrated organizational and coordination skills
- Outstanding written, verbal and problem solving skills
- Proficient in word processing, PowerPoint presentations and computer databases
- Quality Assurance
- Quality Control
- cGMP Manufacturing
- Project Management
- Clients
- Consultants
