What are the responsibilities and job description for the Quality Assurance Generalist II (4:00PM - 12:30AM) position at Fagron Sterile Services?
About the job
Job Summary :
The Quality Assurance Generalist II is an intermediate level professional position responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition. Ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products.
The What?
- Execute and develop proficiency in all Level 1 and Level 2 Quality Assurance tasks :
- Level 1 :
o Manufacturing / Packaging Line Clearances
o Product Label Review and Approval
o Product Label Reconciliation
o EMS Data Review o Logbook Review and reconciliation
o Batch Record Issuance
o Batch Record Review and Approval
o Incoming Material Review and Approval
o Form and Logbook Issuance
o Review and Approval of Testing Data
o Review and Approval of Event Reports and Associated Corrective Actions
The How?
Maintain the Fagron Family Values of Quality, Customer is #1, Transparency, Entrepreneurship, Creativity, and Speed of Execution while performing job responsibilities.
Follow Fagron Family Rules
Contribute to QA Team success by participating in problem solving discussions and seeking to understand the "Why?"
Strive for continual learning and improvement
Set yourself apart
Basic Qualifications
Proficient in MS Office programs, including Word and Excel.
Core Competencies
What's on offer?
Our Benefits
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to :
The FSS Boston facility is in beautiful Canton, Massachusetts. Employees enjoy ample parking at a state-of-the-art compounding facility. The employee breakroom provides plenty of storage for lunches and you can enjoy free coffee anytime of the day!
