|Interested? Email Us||Never Applied? Apply|
|Quality Systems Specialist|
|Hours:||40 Monday to Friday 8am to 5pm|
|Great Opportunity Available in Camarillo|
The Quality System Associate will lead the development, administration and execution of the GMP CAPA Program, which includes the Deviation, Corrective Action and Preventive Action CAPA, and Supplier Corrective Action Request SCAR processes. This role is responsible for improving the CAPA Program, providing oversight for the processes, training impacted staff, executing investigation, action implementation, and effectiveness verification activities as assigned, and reporting progress to Operations management. Responsible for the development and execution of the GMP CAPA program and processes for packaging, equipment, facility and procedural changes. Provides oversight for all GMP CAPA Program records. Supports change owners in the writing, executing and administration of Deviation, CAPA, and SCAR records. Collaborate with change owners as necessary to facilitate completion of CAPA program activities. Ensures activities are executed per Standard Operating Procedure. Tracks timeliness of Deviations, CAPAs, and SCARs against pre-defined milestones. Determines key quality indicators for the GMP CAPA program and process. Reports Deviation, CAPA, and SCAR status and progress to Operations management. Owns projects as assigned. Collaborate with Deviation, CAPA, and SCAR owners. Helps drive a culture of continuous improvement. Assist with regulatory and 3rd party inspections. Establishes a good quality of work. Participates in team meetings and strategizing sessions. Participates in continuous improvement initiatives. Behaves ethical in all situations and reports or challenges unethical behavior of others. Performs other tasks as assigned.
HS Diploma. 2+ yrs exp in pharmaceutical operations. Working knowledge of FDA GMP and quality system regulations and manufacturing processes.
BA Degree in health sciences. Internal auditing exp.