QA Associate (GMP/CAPA)

Description:

100% Onsite - HQ-Thousand Oaks (USTO)

In this vital role you will be part of the Manufacturing Technical Operations (MTO) Production Process Owner (PPO) team which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, supporting the multiproduct facility operation program, CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug product supply organization in ATO Building 20 which is a dynamic environment and an important launch point for Client pipeline products. The plant manufactures drug product at all phases of clinical trials through commercial production.

Responsibilities include:

• Support manufacturing by providing subject-matter expertise for drug product vial and syringe filling processes as production process owner (PPO)
• Lead sophisticated projects or parts of projects using project management skills.
• Resolve quick issues and execute function tests to troubleshoot and optimize process
• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
• Own Quality Records, such as CCMS, CAPA, and CAPA-EV.
• Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
• Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
• Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
• Demonstrate strategic problem-solving skills and champion continual improvement.
• Ability to be on-site (flexible worker)
• Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
• Develop/own drug product manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.
• Support New Product introduction and projects through SUS mapping
• Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigation and bring leaks and defects to triage
• Initiate EN/SICAR records and follow process to conclusion, including working with vendors on investigation.
• Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects
• Understand single-use material capabilities and user requirements for new technologies.

Basic Qualifications

Master’s degree Or

Bachelor’s degree and 2 years of manufacturing and operations experience Or

Associate’s degree and 4 years of manufacturing and operations experience Or

High school diploma / GED and 6 years of manufacturing and operations experience

Top 3 Must Have Skill Sets:

Project Management

Communication Skills

Willingness to Learn