OTC Stability Specialist II

Reporting to the Technical Services and OTC Stability Manager, the OTC Stability Specialist II will partner with R&D serving as Subject Matter Expert for compliance, test method development and stability study initiation. The role involves coordinating protocols, study placement and execution that support the assignment of expiration dates. It also requires leading OTC Chamber monthly audits and participating in internal, corporate, and external audits representing the OTC Stability Program. Collaboration with internal (QA, Planning) and external (3PM) partners is essential to monitor and coordinate annual study placement confirming tentative expiration date. What you will do: Work with R&D and Project Management to determine required OTC drug product stability studies and coordinate with QA and Planning to place annual studies confirming tentative expiration dates. Confirm adequate data exists to support the expiration date assigned to OTC drug products; maintain an SLED document reflecting assigned dates based on stability data. Monitor all OTC drug stability processes per written procedures and current regulations; maintain accurate inventory records, ensure GMP compliance for stability chambers, and lead reviews and maintenance of work instructions and SOPs. Respond to operational compliance excursions, lead root‑cause determinations, and coordinate resolution with plant services. Initiate quality events and lead CAPAs. Facilitate analytical method development and method transfer validation by coordinating with the method team, and 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 labeling and placement of samples in stability chambers for ongoing and annual stability studies; track sample submission and results to ensure required timing. Accurately maintain and report stability data including investigation reports for out‑of‑specification data; circulate reports for review and approval by management. What you will need: Bachelor's degree in Chemistry, Microbiology or related disciplines. 5+ years of quality or analytical laboratory experience. 5+ years applying current Good Manufacturing Practices (cGMP) concepts. 3+ years of actual stability study coordination or execution experience. Benefits: At Kao, we offer benefits available from day one of employment, including healthcare, a 401(k) plan with company match, 36 total days off (vacation + holidays + sick), and a salary range of $80,000 — $90,000. Equal Opportunity Employer Kao USA is an equal opportunity employer, including for disability and veteran statuses. #J-18808-Ljbffr AFM - Association Française du Marketing