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Quality Specialist

Location: 

Ormond Beach, FL, US

Req ID:  1945
Job Type: 
Edgewell is a global team of over 6,000 visionaries, doers and makers. Our secret is people, and we have an inspiring and collaborative global force of them. Our portfolio of over 25 brands touches lives in more than 50 countries by making useful things joyful. Together, we reimagine good mornings and endless summers, strive for more sustainable ways to beautify and bond, and do it all with not only confidence but determination.

Position Summary

Coordinates the day to day activities of quality specialist in the review of quality records to ensure that all product meets compliance requirements.  Lead various compliance functions such as CAPA Management, annual GMP training, performs final review of all non-conformance investigations, and supports monthly Compliance Steering Committee meeting.  Reports to the QA Lab Systems Supervisor and collaborates closely with the Management of Manufacturing, Planning and Compounding.

 

Universal Accountabilities

 

  • Ensure compliance to all FDA requirements.
  • Ensure compliance to Health Canada requirements.
  • Utilize computer systems for managing the quality units information (Track-Wise, e-Performance, SAP, Minitab, Microsoft, etc.).
  • Motivate the team and provide coaching and mentoring to direct reports.
  • Minimize the risk and exposure to non-conformances and compliance gaps.
  • Oversight of all quality investigations to ensure timely closure.
  • Plans, executes, and evaluates continuous improvement in quality and process control.
  • Assures that corrective actions are taken to eliminate the causes of non-conforming product.
  • Determines and reports the principal cause of failures and non-conformance.
  • Insure that organizational systems and training is in place.
  • Ensuring that documentation and design controls are appropriate for organization.
  • Elevate quality issues above the Value Stream Quality Assurance Manager.

 

Specific Accountabilities

  • Supports and works on site batch release.
  • Ensures data integrity with all direct reports.
  • Consumer Complaints.
     

Required Skills and Experience

  • ASQ Certifications such as CQIA a plus.
  • 3-5 years’ experience in a regulated business.
  • Bachelor's degree and up to 1 year of experience or equivalent of and 5 years 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

 

  • Thorough knowledge of regulatory requirements and limitations.
  • Working knowledge of FDA regulated products.

 

Working Relationships

  • Internal contacts: Cross-functional team (Purchasing, Operations, Quality, Engineering, Human Resources, technical support groups) as well as other regulated sites.

 

  • External contacts:  Suppliers, contract manufacturers, consultants, contract laboratories, research organizations – technical partnerships such as trade organizations.

 

Edgewell is an equal opportunity employer. We do all we can to create a collaborative and diverse global team, where good ideas can thrive, and our colleagues can learn and lead. 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 legally protected status in accordance with applicable federal, state and local laws. We listen deeply and speak directly to create an environment that’s open to difference. We aim to bring joy to not only the products we create and the people we serve, but our colleagues across the globe too.


Nearest Major Market: Daytona Beach