Coordinator, QA

PLZ is committed to product stewardship and innovation, strong ethical standards, sustainable operations and most importantly, the development of our people. Whether at our manufacturing facilities or corporate headquarters, PLZ prioritizes health and safety, and offers you the support you need to create the career you want, through engagement, equity and inclusion, and opportunity.

The QA Coordinator is responsible for supporting quality systems, documentation, audits & training in GMP environment adhering to the ISO and FDA GMP regulations and follows SOPs, GMP, GLP and GDP. Additional responsibilities such as QM back up.

• Manage Customer Complaints, Non-Conformance, Change control, Deviation, CAPA, and similar activities
• Perform investigations of complaints and non-conformances. Tracks status and maintains established deadlines for completion of review and corrections.
• Create and revise SOPs. Work Instructions, Forms, Policies, One Point Lessons and other controlled documents to support compliance to GMP.
• Track and ensure that audit responses are on track.
• Validation and Qualification activities
• Set up training documents for new personnel and current employees for updated SOP, Forms and other documents as required.
• Participate in internal and external audits.
• Manage and perform FMEAs
• Creation of flow charts, spaghetti diagrams, etc. to assist in implementing lean six sigma methodology.
• Use SMED to reduce changeover time
• Assist with root cause analysis
• Assist with implementation of 5S
• Other duties as assigned
• Wear personal protective equipment
• Follow company safety policies, rules and regulations
• Participate in practice evacuation drills—know where the nearest exit is located, as well as nearest fire extinguisher, eyewash station, shower and exit are located.

Requirements :

skills.

Ability to work independently on tasks with little supervision

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or other protected status. EEOE / M / F / Vet / Disabled. All your information will be kept confidential according to EEO guidelines.