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Quality Specialist

Location: 

Dover, DE, US

Req ID:  755
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 Summary

This position will perform work that is crucial to the control, security, and integrity of documents and data that is used in the review and release of Edgewell Personal Care’s products.  Under direct supervision, this position is responsible for conducting routine tasks within the Quality Assurance program comprised of data review and confirmation of results against known standards. 

Universal Accountabilities

  • Reviews and approves device history records in support of final product release.
  • Issues nonconformances related to documents and products.
  • Generates certificates of analysis for products when applicable.
  • Communicates information and results to the Quality Supervisors and to the applicable departments.

Specific Accountabilities

  • Ensures data collected during testing and manufacturing are accurate and complete. 
  • Performs basic database and document-control functions. 
  • Aids in the development of procedures.
  • Promotes and exercises good documentation practices on hard copy and electronic records.
  • Communicates any unexplained discrepancies or deviations to Supervisor or applicable departments to ensure proper investigation is conducted and documented.
  • Promotes and adheres to document 3-year review policy.
  • Performs records management and record retention activities for documents and quality standards.
  • Aids in development and training of procedures. 

Required Skills and Experience

  • Typically requires a diploma and 5 years of experience or Bachelors and less than 1 year of experience.
  • 3-5 years proven track record in the use of databases or electronic systems.
  • Extremely organized and detail oriented.
  • Excellent communication skills, written and verbal.
  • Excellent Microsoft Office skills.

 

Preferred Skills and Experience

  • ASQ Certifications such as CQIA a plus.
  • 3-5 years’ experience in a regulated business.
  • Working knowledge of regulated industry standards such as 21 CFR Part 820, 21 CFR Part 11, ISO 13485, etc.

 

Working Relationships

  • Reports to the Quality Supervisor.
  • Key internal relationships will include Operations, Manufacturing, Quality Assurance, Quality Control, and R & D.
  • Potential key external relationships may include Distribution Center personnel

Work Environment

  • Long periods of sitting, researching, and typing.
  • Work schedules that vary from typical business hours (rare, but may be required).
  • Exposure to conditions that may require the use of Personal Protective Equipment (hairnets).

 

Environmental, Health and Safety Responsibilities

  • Conform to safety regulations and procedures to maintain a safe working environment.
  • Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
  • Performing 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 safely equipment/devices, guarding, as well as safe work practices.
  • Immediately reporting every job-related injury or illness, regardless of severity, to a team leader/supervisor
  • Assist in investigating incidents as directed.
  • Taking necessary actions to correct or stop unsafe conditions or practices.
  • Actively participation in safety meeting and training
  • Review SDS instructions before working with any chemicals or hazardous materials.

 

Quality 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.
  • Colleagues are responsible for notifying leadership for corrective action if defects are found and/or parts/processes do not conform to specifications.
  • Colleagues are responsible for adhering to current Good Manufacturing Practices (cGMP) work rules as they relate to job-specific duties.

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.

 

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Nearest Major Market: Delaware
Nearest Secondary Market: Dover