Primary Function of Position:
Oversee and plan daily activities for Product Release team and coordinate workload to ensure appropriate manpower is assigned to required activities.
Verify that Product Release tasks are well defined, as well the Product Release team is productive and processes are compliant to ISI Operating procedures and instructions. Ensure training is appropriate and timely for the Product Release team, Review and approve timecard submissions and related requests.
Verify manpower planning is aligned to internal customer demand, current and projected, Review individual contributors’ performance and mentors as appropriate to continuously improve Product Release performance.
Roles & Responsibilities:
- Supervises Product Release personnel at assigned plant(s).
- Performs individual contributor performance reviews, timecard management, and mentoring for assigned plant.
- Establishes and manages Monthly / Weekly assignment of DHR, optimizing actions based on demand and manpower.
- Manages daily Product Release operations to ensure compliance to regulatory requirements including GDP & GMP.
- Reviews NCR and DN trends, taking action where necessary to drive down average duration and recurring incidents.
- Support Quality audits to manage accurate data required previous, during and after audit events.
- Manage sterilization lots release according to data provided by sterilization suppliers and escalates adverse specification data or extended delivery dates.
- Keep KPI of Product Release updated accordingly frequency required by Quality Management.
- Support multiple sites on SOP, DOP, WI documents update, and upgrade related to Product Release.
- Fluent on English speaking and writing (80% or above).
- May also support or assist the following Lead Activities:
- Verifies Product Release operations performance in accordance with procedures and instructions.
- Conducts training of Product Release personnel on DHR Review, SAP, Agile, Sterile product management, Bracketing and other Quality transactions.
- Performs periodic audits to verify correct and consistent operations and timely execution of tasks
- Ensures Product Release budget department is controlled and if required over expend justification or continuous improvement for budget reduction
- Generates and maintains DHR reports for monthly quality review meetings
- Manages NCRB areas to control non-accepted product to been wrongly used
- Provides guidance and training to Product Release team when required.
- Performs any other projects or duties that may be assigned.
- Support lot release of multiple ISI sites
Skills, Experience, Education, & Training:
- Engineering studies or Accountant BS in progress is accepted, BS in Engineering or Accountant preferred + 2-5 years related experience or training; or equivalent combination of education and experience.
- Experience in Agile is preferred
- Requires understanding of ERP Information Systems, preferably SAP.
- Must be proficient in the Microsoft Office suite of programs, specifically Excel.
- Proficient in English (spoken and written)
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.
