Quality Assurance Associate

Title:

Quality Assurance Associate

Company:

Ipsen Bioscience, Inc.

Job Description:

Summary / purpose of the position

This position in the Quality Assurance group is responsible for the quality oversight of GMP manufacturing activities at Ipsen Cambridge Manufacturing US. The successful candidate will support daily GMP manufacturing activities involving compliance with applicable regulations for cGMP requirements.

Main Responsibilities / Job Expectations

• Reviews and gets approval for batch documentation and release in accordance with relevant regulatory requirements. Support QA manager and manufacturing personnel to address any issues
• Support raw materials and components release process for use in manufacturing
• Responsible of log books and controlled forms issuance and reconciliation as well as periodic approval of critical log books
• Compiles, reviews and approves cGMP Documentation
• Support on site and off site storage activities for GMP records
• Perform internal cGMP walk-downs and self inspection of multiple operations.
• Assists in Root Cause Analysis investigations as required offering a quality perspective on any deviations.
• Supports Change Control Activities - Documentation, Process, Equipment.
• Participates in Quality Management Processes. Supports routine quality activities and continuous improvements
• Supports on-site inspections by all external regulatory bodies.
• Supports validation activities from a quality perspective including process, facilities and systems.

Knowledge, Abilities & Experience

• Bachelor’s degree in Science or related experience
• 2 + years’ experience in a Quality Assurance GMP environment (Pharmaceutical / biotechnology industry - commercial experience preferred)
• Must demonstrates strong knowledge of quality SOPs and systems and their implications on other systems
• Identifies discrepancies and suggests resolution or improvements based on a clear understanding of quality SOPs.
• Is able to identify and highlight routine problems that could lead to risks down the line and escalates as needed.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.