Quality Systems Associate

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. Monday-Friday 8am-5pm $24.04-$28.85/hour +

Benefits Responsibilities:

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. Performs other tasks as assigned.

Qualifications:

HS Diploma or GED 2+ years experience in pharmaceutical operations preferred Working knowledge of FDA GMP and quality system regulations and manufacturing processes

Job Type:

Full-time Pay:

$24.04 - $28.85 per hour

Work Location:

In person