Quality Associate II/III, QA (Packaging)

GRIFOLS, S.A.•NC-Clayton, CA

10d•Onsite

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Quality Associate II The Quality Associate II, Quality Assurance for QA Packaging provides routine technical support for various tasks (i.e. documentation, training, compliance, product release, scheduling, etc.), assignments, projects, etc. He/she may be responsible for coordinating work assignments and training of other employees. In addition to the duties described above the Quality Associate II, Quality Assurance may also perform the following duties based upon the business unit to which he/she is assigned: Quality Associate Ill The Quality Associate Ill, Quality Assurance for Packaging QA 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. Fully qualified professional who requires minimal supervision. In addition to the duties described above the Quality Associate Ill, Quality Assurance may also perform the following duties based upon the business unit to which he/she is assigned: Responsibilities may include roles (such as author, reviewer, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality at business unit.

Requirements

QA work experience
experience reviewing BPRs
Possess excellent organizational skills
communication skills
detail oriented
is very efficient
BS/BA degree preferably in a STEM (Science, Technology, Engineering, or Mathematics) and a minimum of 2 years of related experience, or equivalent combination of education and experience (for QA II)
BS/BA preferably in a STEM degree with minimum of 3 years relevant experience, or equivalent combination of education and experience (for QA III)

Responsibilities

Collects, reviews, and may analyze data.
Makes decisions within a well-defined area.
Addresses and resolves problems according to written procedure (i.e. SOP, etc.) or practice.
Communicates effectively and promptly, 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.
Develops alternative solutions to problems
Demonstrates strong technical expertise and ability to adapt to changing circumstances.
May train employees.
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.
Responsibilities may include roles (such as author, reviewer, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.
Responsible for representing Quality at business unit.