MCS Manufacturing Sr. Associate-MES/Validation
BioPharma Consulting JAD Group
Thousand Oaks, california
Job Summary:
The Senior Associate, Manufacturing will join the New Product Introduction (NPI) team. This role is crucial to managing the successful introduction of new products, with responsibilities spanning project management, change control ownership, and collaboration with cross-functional teams to support product launches and maintain compliance.
Key Responsibilities:
- Lead and manage New Product Introduction (NPI) and non-capital projects, ensuring successful project execution and compliance with GMP standards.
- Own change control processes, ensuring records meet regulatory standards with a "Right the First-Time" approach.
- Facilitate and ensure timely closure of change control records, following procedural guidance and timelines.
- Represent as the receiving site for new Technology Transfers and NPIs.
- Identify and advocate for improvement opportunities within the organization, building...