Sr. Quality System Associate

Camarillo Job Description

The Sr. Quality System Associate will lead the development, administration and execution of the GMP Quality Systems Programs, which includes the Change Control, Validation, Stability, Training, Document Control, Management Review, Deviation, Corrective Action and Preventive Action CAPA, and Supplier Corrective Action Request SCAR processes. This role is responsible for improving Quality System Programs, providing oversight for the processes, training impacted staff, executing investigation, action implementation, effectiveness verification activities as assigned, and reporting progress to Operations management.

Responsible for the development and execution of the GMP Quality Systems Programs, which include but are not limited to Change Control, Validation, Training, Document Control, Management Review, Deviation, CAPA, and SCAR processes. Provides oversight for GMP Program records. Supports GMP record owners in the writing, executing, and administering of various Quality System records. Collaborate with record owners as necessary to facilitate completion of Quality System program activities.

Ensures activities are executed per Standard Operating Procedure. Tracks timeliness of GMP records against pre-defined milestones. Determines key quality indicators for the Quality System program and process. Reports Quality System record status and progress to Operations management. Owns projects as assigned. Assist with external audits. Participates in team meetings and strategizing sessions. Participates in continuous improvement initiatives and help drive a culture of continuous improvement.

HS Diploma or GED. 2+ yrs exp in pharmaceutical operations. Working knowledge of FDA GMP regulations and quality systems requirements. Knowledge of pharmaceutical manufacturing processes.

BA Degree in health sciences. Internal auditing exp.