OTC Stability Specialist II

Kao Corporation•Cincinnati, OH

3d•Hybrid

About The Position

The OTC Stability Specialist II will partner with R&D serving as Subject Matter Expert for compliance, test method development and stability study initiation. You will coordinate protocols, study placement and execution supporting expiration date. You will lead OTC Chamber monthly audits and participate in internal, corporate, and external audits representing the OTC Stability Program. You will collaborate with internal (QA, Planning) and external (3PM) partners to monitor and coordinate annual study placement confirming tentative expiration date.

Requirements

Bachelor's degree in Chemistry, Microbiology or related disciplines
5+ years Quality or Analytical Laboratory experience
5+ years application of current Good Manufacturing Practices (cGMP) concepts
3+ Years actual Stability Study Coordination or Execution Experience

Responsibilities

Work with Research & Development (R&D) and Project Management to determine OTC drug product stability studies that are required to be placed to establish expiration date.
Coordinate with QA and Planning to monitor, obtain, and place annual studies confirming tentative expiration date.
Confirm adequate acceptable data exists to support the expiration date assigned to OTC drug products; maintain SLED document to clearly reflect the assigned expiration dates based on stability data.
Monitor all OTC drug stability processes according to written procedures and in accordance with current regulations; Maintain accurate inventory records and ensure GMP compliance for stability chambers.
Lead review and maintenance of work instructions and standard operating procedures.
Respond to operational compliance excursions, lead root cause determinations and coordinate resolution and maintenance issues with plant services.
Initiate quality events and lead CAPA's.
Facilitate analytical method development and method transfer validation by coordinating as appropriate with method team resources.
Serve as SME for determining significance of formulation changes and stability placement.
Lead QM change control associated with formulation changes.
Develop protocol, request samples, and coordinate the label and placement of samples in stability chambers for both ongoing and annual stability studies.
Track samples submitted and results received so as to maintain required timing.
Accurately maintain and report stability data including investigation reports for out of specification data; circulate reports for review and approval by management.
Initiate quality events and lead CAPA's.