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Coordinator, QA

PLZ Aeroscience CorporationIndianapolis, IN

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Job Description

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.

From household cleaning solutions to personal care products, and food to automotive lubricants, PLZ produces more than 2,500 different aerosol and liquid products in our facilities across the continent. We know that being the partner of choice for our clients starts with being the partner of choice for our employees. Learn more at www.plzcorp.com/careers or visit https://youtu.be/XYNIFpLQIJY

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:

  • HS Diploma or GED
  • Minimum 2 years' experience working in a GMP environment.
  • Experience in documentation, Quality Systems and SOP management.
  • Experience in Lean Six Sigma Excellent organization/multitasking and communication skills
  • Problem-solving using internal and external resources
  • Must have excellent verbal, written and interpersonal communication

skills.

  • Detail oriented, understand the importance of complete and accurate documentation.

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.

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