The role is responsible for providing functional support for Analytical Standards and Analytical change control activities across a global manufacturing network
Job Summary
The role is responsible for providing functional support for Analytical Standards and Analytical change control activities across a global manufacturing network.
Candidates must ensure all analytical changes are compliant with current Good Manufacturing Practices (cGMP) and regulatory expectations.
The position requires maintaining active ingredient and final product Analytical Standards while collaborating with stakeholders in Regulatory, Technology, and Supply Chain.
Matching Summary
The role is responsible for providing functional support for Analytical Standards and Analytical change control activities across a global manufacturing network.
Skills & Requirements
Must-have
10 years applied professional work experience
Change Control and Laboratory Operations
cGMP compliance knowledge
Analytical Standards document management
Regulatory and compendial requirements
Nice-to-have
Superior written and oral communication skills
Advanced problem solving and decision making
Ability to lead teams with competing priorities
Creative thinking and resourcefulness
Proficient computer skills
Key Requirements
BS degree in life sciences, engineering or related discipline
Minimum of 10 years experience in Change Control or Quality operations
Strong technical knowledge in laboratory oversight