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Quality Specialist (Personal Care) en PLZ Corp

PLZ Corp · Indianapolis, Estados Unidos De América · Onsite

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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 Quality Specialist 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 Quality Manager back up.

 Key Responsibility:

  • Create and revise SOPs. Work Instructions, Forms, Policies, One Point Lessons and other controlled documents to support compliance to GMP standards.
  • Participate in customer and regulatory audits. Track and ensure that audit responses are on track. Support QA Manager in authoring audit CAPA plans and implementing CAPA initiatives.
  • Validation and Qualification activities, including authoring validation protocols for Installation, Operation, and Performance Qualifications
  • Participate in internal and external audits.
  • Partner with Operations and Engineering to ensure compliance with scheduled environmental monitoring, Pest Control, Preventative maintenance, and Calibration
  • Assist with root cause analysis and technical writing of Nonconformances, Deviations and CAPA plans
  • Must have the ability to wear personal protective equipment and 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.
  • Other duties as assigned

 Qualifications:

  • Bachelor’s degree and minimum 2 years’ experience working in a GMP environment or High School Degree with Minimum 10 years of experience
  • Experience in documentation, Quality Systems and SOP management in a cGMP environment
  • Experience with root cause analysis tools including but not limited to fishbone diagram, 5 why and FMEA
  • 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 as well as within a cross functional team.

PLZ Corp offers a robust suite of benefits including:

  • Medical, Dental & Vision benefits.
  • Company paid Life and Short-Term disability.
  • Voluntary benefits including additional life, disability, and hospital/accident insurance.
  • 401k & company provided match.
  • Paid Time Off
  • Bonus incentive programs (Note, bonuses are subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.)

 

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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