Quality Associate III

GRIFOLS, S.A.•Oceanside, CA

2d•$83,389 - $125,083•Onsite

About The Position

The Quality Associate III, Quality Assurance demonstrates consistent application of technical knowledge and expertise (i.e. documentation, training, compliance, product release, scheduling, etc.), assignments, projects, etc. Executes assignments of medium complexity and develops solutions to defined problems for Quality Assurance. He/she may be responsible for coordinating work assignments, training other employees. Able to work independently with minimal supervision.

Requirements

Excellent communication skills (written and verbal).
Has basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
Bachelor’s Degree preferably in a STEM degree with minimum of 3 years relevant experience, or equivalent combination of education and experience.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Responsibilities

Managing customer specifications and associated documentation like CoA, agreement. This includes creation/revision through controlled change control process
Responsibilities may include roles within quality systems but not limited to Change Control, Discrepancy Management, CAPA, Quarantine, Batch Release, SAP, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, clinical studies, stability studies.
Develops alternative solutions to roadblocks and delays
Demonstrates strong technical expertise and ability to adapt to changing circumstances.
Makes decisions with designated assignments that influence the goals of the department.
Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
Demonstrates high levels of values and integrity.
Follows cGMP and department safety practices.
Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.
Responsible for representing Quality at business unit meetings, and project meetings.
May train employees.
Collects, reviews, and may analyze data