Associate Quality Analyst II - Barceloneta, Puerto Rico - Weil Group, Inc

Descripción

Shift:
Disponible para los 3 turnos y rotativos de ser necesario incluyendo weekends. Rotating shift and weekend – based in business needs
EXEMPT POSITION
This is a new position/schedule. workers should be available to work on rotating shift every week due to 24/7 new business operation. final schedule still under revision.

During routine operations, the Associate SVP Quality Analyst is responsible for carrying out Manufacturing Quality Assurance functions within the plant including performing Line Inspections, Quality Visual Inspections and Tub Hold management process.

The incumbent supports the visual inspection certification process, resolution of deviations, participating in investigations, and assurance of compliance with cGMP and Client policies for the manufacturing plant.

Key Accountabilities/Core Job Responsibilities:

• Responsible for performing the SVP Line Inspections, Quality Visual Inspection (i.e. AQL) and provide support for the Tub Hold Management process.
• Supports Visual Inspection Certification Process. May act as Subject Matter Expert (SME) for the Visual Inspection Process.
• Support quality goals ensuring that all practices and procedures comply with GPO and Corporate policies and applicable regulations for the Quality areas under his/her responsibility.
• Support SVP Media Fill Program and QA Oversight execution activities.
• Place product on QA hold when required. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Revise standard operating procedures; ensures procedures comply with Client policies and cGMP guidelines.
• Demonstrates accountability and responsibility of EHS performance and compliance Additional requirements that we are looking for are:
• Aseptic processing experience
• Quality Assurance experience
• Visual inspection of parenteral products experience
• Participation and/or experience in Aseptic Process Simulation (Media Fills)
• Prior experience/certification in sterile gowning
• 
  Prior experience in surveillance of aseptic filling process is a plus

Qualifications

Education, Qualifications and Experience Requirements (degree, certifications, etc.):

Education:
Bachelor degree in biotechnology/biopharma, biology, chemistry or engineering. Pharmaceutical experiences can be considered. Master degree is not needed. at least 1 year biotechnology/biopharma with aseptic processing experience is desired.

**Weil Group is proud to be an Equal Employment Opportunity Employer.*