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Sr. 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.

 

 

POSITION EVALUATION SPECIFICATIONS

 

POSITION TITLE:              Senior Auditor, QA Global Compliance                            

 

DEPARTMENT POSITION IS LOCATED IN:   Edgewell site USA

 

REPORTS TO: Director, QA Global Compliance

 

POSITION SUMMARY:

 

This position is responsible for:

  • Performing GxP, Drug, Cosmetic audits, including audits of Manufacturing and R&D sites, vendors, to assess regulatory compliance.
  • Applying audit principles, procedures, and method to collect information through effective interviewing, listening, observing and reviewing documents, records and data.
  • Prioritize and focus on matters of significance; Confirm the sufficiency and appropriateness of audit evidence to support audit findings and conclusions.
  • Mentoring of other auditors
  • Providing compliance expertise in regulatory requirements related to GxP, Drug, Cosmetic audits, including audits of Manufacturing and R&D
  • Conducting Regulatory site readiness drills
  •  
    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 degree (BS preferred) and 12 plus years’ experience, in pharmaceutical or related industries including at least four years in quality capacity. Certified Auditor required. CQA, MS preferred.
  • Demonstrates full knowledge, and ability of the primary discipline (Drug, CPSC compliance) and a complete knowledge of related disciplines through a combination of technical, product development and regulatory compliance experience in industry thorough understanding and working knowledge of Quality systems and tools. Knowledge of 21 CFR 210 & 211 , Health Canada Regulations . ASQ, RAPS, ISO certification preferred. Experience with Trackwise, 123 Compliance a plus
  • Demonstrates working knowledge in other Quality Systems such as Microbiological controls, Laboratory controls, process validation, recall management, management reviews or escalation/ emergency management, Compliance Manual
  •  

 

ENVIRONMENTAL, HEALTH AND SAFETY RESPONSIBILITIES:

  • Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
  • Perform every job safely, for the benefit of self, co-workers, contractors, and for the protection of facilities.  This includes the use of required personal protective equipment and use of safety equipment as well as safe work practices.
  • Immediately report every job-related injury or illness, regardless of severity, to a supervisor.
  • Assist in investigating incidents as directed by your supervisor.
  • Take necessary actions to correct or stop any unsafe conditions or practices.
  • Actively participate in safety meetings and training.
  • Review and become familiar with the contents of the SHARP Manual.
  • Review Material Data Sheet instructions before working with any chemical product.

 

QUALITY ASSURANCE RESPONSIBILITIES:

  • Colleagues are responsible for their own quality and that of colleagues within their span of control. 
  • Colleagues are responsible to follow all established Quality procedures and instructions. 
  • Notify supervision for corrective action if and when defects are found and/or parts/processes do not conform to specifications.

SUPPLEMENTARY INFORMATION:

This description is based on management’s assessment of the requirements and functions of the job as of the date of this description was prepared.  It is a general guideline for managers and employees, but it does not purport to be an exhaustive list of all the elements of the job.  Management reserves the right to modify the description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet production, scheduling or staffing needs.

 

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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.

 

 


Nearest Major Market: New Jersey