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Sr Quality GMP Auditor

Location: 

Allendale, NJ, US

Req ID:  706
Job Type: 

We are a global team of 6000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

 

 

Can work from any Edgewell location (Shelton CT, Allendale NJ, Milford CT, Dover DE, Sidney OH, or Ormond Beach FL).

 

Do you love auditing and helping establish best practices?  Do you want to work for an industry trailblazer who is leading with a people first mentality?  Can you travel 40-60% of the time?  We are looking for a team player that can lead GxP, Drug, Cosmetic audits, including audits of Manufacturing and R&D sites, vendors, to assess regulatory compliance.   You will apply audit strategies, principles, procedures, and methods to collect information through effective interviewing, listening, observing and reviewing documents, records and data.  Then report on the audit findings and conclusion. 

 

You will be facilitating the readiness of Edgewell entities and associated functions for regulatory authority inspections to ensure adherence to current applicable requirements. You will be managing the audit schedules and audit deliverables.  You will also be participating and leading compliance improvement projects.   If this sounds like a job you are interested in and you want to be part of a company, you can bring your whole self to and be proud of, then we are interested in speaking with you!

 

 

ESSENTIAL FUNCTIONS:

  • Lead, participate in assigned audits.
  • Prepare clearly-written, concise, accurate and evidence-based audit report.
  • Review and assess received corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence.
  • Maintain an in-depth knowledge of governmental regulations impacting manufacturing and research.
  • Mentors/ trains other auditors.
  • Routinely provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of Quality Systems.
  • Demonstrate initiative in the timely resolution of problems.
  • Anticipate and identify future needs in related quality disciplines.
  • Anticipates compliance trends and interprets their implementation.
  • Participate and/or manage other Global Compliance Quality systems: Recall, Escalation of issues, Compliance Manual.
  • Generate schedules, procedures, reports, metrics and presentations as required.
  • Lead other auditors in the group as required by the program
  • 40-60% travel

 

OTHER DUTIES AND RESPONSIBILITIES:

  • Participate in cross functional teams for assessments, root cause, gap, trend, impact and risk analysis as required.
  • Coordinate agency inspection readiness activities.
  • Participate or support regulatory agency inspections.

 

EDUCATION AND EXPERIENCE:

Scientific Bachelor’s degree (BS preferred) and 12 plus years of relevant experience.  

 

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Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.