Associate Quality Analyst in Barceloneta, PR

Work Schedule - rotating shifts to cover 24/7

Description Details

During routine operations, the Associate SVP Quality Analyst is responsible for carrying out Manufacturing Quality Assurance functions within the ABL 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.

• 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

Technical Skills:

• Good verbal and written communication skills in both Spanish and English
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills

Experience Requirements:

• This position requires knowledge in: quality / compliance management, visual inspection AQL and Visual Inspection certification processes, aseptic processing operations, as well as regulations and standards affecting Biologics and Parenteral applications.

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

The combination of experience in one or more of the additional requirements listed below is a plus:

• 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

What type of environment is this person working in?

• Group setting
• Individual Setting
• Combination of both

Work Schedule - rotating shifts to cover 24/7

Does this position offer the ability to work remotely on a regular basis or is it an on-site role?

• No, 100% on site

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