Job Details

Requisition Number 19-0330
Post Date 12/26/2019
Title Quality Systems Supervisor
City Montvale
State NJ
Description

Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products. 

We're currently looking for a Quality Systems Supervisor in our Montvale, NJ location.

POSITION PURPOSE:

The purpose of this position is to ensure all controlled documentation is properly prepared, revised, reviewed, approved, distributed, expired, and retained according to the appropriate NP/PDI procedures and external standards. This position will serve as an Electronic Document Management System (EDMS) administrator and train/qualify internal users.

ESSENTIAL FUNCTIONS AND BASIC DUTIES:

SYSTEM MANAGEMENT: 25%

  • Review, prepare, execute, approve, assist with, and maintain applicable Change Management and Validation documentation for retrospective, concurrent, and prospective validation compliance specific to EDMS.
  • Assist with current and future electronic processes and workflows in the QMS.
  • Configure data as EDMS Administrator as required for system updates.

TECHNICAL EXPERTISE:

DATA ENTRY & INTEGRITY:

Compose Assessments and Qualification Schemes

Migrate data as required for system updates

Ensure Curriculum Compliance

Configure Data for system updates

Deliver Training              

 

DOCUMENT PROCESSING: 20%

  • Review change requests and documentation for compliance.
  • Process all change requests and documents for review, approval, and issuance.
  • Distribute copies of controlled documentation as requested.
  • Ensure revision control of all controlled documents.
  • Purge obsolete documents per procedure.
  • Process periodic review routings.

CUSTOMER SERVICE: 15%

  • Assist internal customers with technical support and status inquiries.
  • Provide copies of documentation for internal and external distribution.

TRAINING: 15%

  • Train organization on the functionality of the electronic document management system.
  • Develop Content.
  • Maintain all electronic document management system training documentation.

REPORTING & ANALYSIS: 10%

  • Create monthly trending reports and metrics for Quality Review Committee (QRC), Quality/Regulatory Management Team (QRMT), and others as appropriate.
  • Deliver departmental metrics as requested.
  • Analyze and plan upgrade strategies to ensure compliance.

DEPARTMENT/PEOPLE MANAGEMENT: 10%

  • Assist with maintaining departmental procedures and processes.
  • Assist with management of Document Control department. This includes work assignments, document distribution, and departmental guidance on document control processes.

AUDITS, INSPECTIONS, AND COMMITMENTS:  5%

  • Participate in the organization and execution of audits and inspections, including personnel, requests, documentation, and process flow.
  • Ensure accurate, thorough, and on-time completion of all Agency and Third-Party Commitments.
  • Maintain documentation and records in accordance with regulations and internal policies.
  • Act as SME for system inquiries during audits and regulatory inspections.

PERFORMANCE MEASUREMENTS:

  • On time completion
  • Robustness of program
  • Effective Metrics and Reporting
  • Values - centered execution
  • Regulatory and GMP Compliance
Requirements

QUALIFICATIONS:

EDUCATION/CERTIFICATION:

  • Bachelor of Science or Bachelor of Arts degree 

REQUIRED KNOWLEDGE:

  • Proficiency in Microsoft Office Suite, Internet Browsers, and Adobe PDF applications. Learning management system experience is a plus.

EXPERIENCE REQUIRED:

  • 4 or more years’ experience with Electronic Document Control Systems. Proofreading experience is a plus.

SKILLS/ABILITIES:

  • Abilty to prioritize daily workload, multitask, and shift scope to meet business needs.
  • Ability to work independently, cross-funtionally, and within a team environment.
  • Possesses strong written and verbal communication skills.
  • Possesses a strong attention to detail and the ability to troubleshoot complex documentation issues with minimal guidance.
  • Knowledge of Quality Management System structure.
  • Cognizant of applicable ISO and CFR standards/regulations.
  • Ability to participate effectively in audits and inspections.
  • Ability to train and qualify EDMS users.
  • Obtains people management skills and ability to motivate peers.

WORKING CONDITIONS:

  • NONE:  No hazardous or significantly unpleasant conditions. Standard office environment. Must be able to sit in front of a computer for extended periods of time.

 

Visit us at Linkedin

 

 

#LI-Nicepak

#LI-AZ1

  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
  • Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
Apply Online
Send This Job to a Friend