Quality Assoc II/III, QA

GRIFOLS, S.A.•NC-Clayton, CA

2d•Onsite

About The Position

The Quality Associate II/III 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 other employees. Execute assignments of medium complexity and develop solutions to defined problems for Quality Assurance. Fully qualified professional who requires minimal supervision. Primary responsibility of this position is final container product release along with other responsibilities listed below. The candidate will be expected to perform batch related activities and meet cycle time releases. He/she must be aware that priorities may change frequently.

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 independently, but within a well-defined area.
Addresses and resolves problems according to written procedure (i.e. SOP, etc.) or practice.
May supervise or train employees.
Communicate effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
Demonstrates high levels of value and integrity.
Follows cGMP and department safety practices.
Responsibilities may include roles (such as author, reviewer) in quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.
Develops alternative solutions to problems, handles complex problems independently.
Demonstrates strong technical expertise and ability to adapt to changing circumstances.
Makes decisions with designated assignments that influence the goals of the department.
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 meetings, and project meetings.