Quality Systems Specialist

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 TILE:

Quality Systems Specialist

DEPARTMENT POSITION IS LOCATED IN:

Ormond Beach

REPORTS TO:

Quality Manager

POSITION SUMMARY:

The Quality Systems Specialist position reports directly to the Quality Manager and is primarily responsible for administrative functions related to SAP, Change Control, CAPA, and Quality Event.  This position is responsible for ensuring Inspection Plans, Component Specifications and Change Control, CAPA, and Quality Event are up to date. This position is also responsible for any other additional tasks assigned by the Quality Management Team. 

ESSENTIAL FUNCTIONS:

• Follow cGMP and 21CFR 210 and 211 requirements for laboratory testing and investigations.
• SAP Inspection Plans
• SAP Master Data
• eBatch characteristics/SAP material masters/SAP FG BOMS
• Review Component Specification
• LIMS Pre Build / Auto Scribe
• eBatch Quality Oversight
• PLM Change Analyst - backup
• Back up for document control, FG review, eBatch characteristics
• EQMS Admin for Change Control/CAPA/Quality Events
• SAP/SharePoint Admin (request new/modify roles)
• DBPR
• Audit Scribe
• G2M FG approvals - backup for Hania
• Maintain a clean and organized work area.
• Follow all EPC Safety/Environmental, GMP (Good Manufacturing Practices) and Lean 5S policies and regulation guidelines.
• Perform other duties as assigned.

OTHER DUTIES AND RESPONSIBILITIES

• Perform job duties in a compliant and safe manner
• Adhere to project deadlines assigned by Quality Management Team
• Escalate non-conformances in a timely manner and in accordance with local and corporate procedures.

EDUCATION AND EXPERIENCE

• Required AA or B.S degree – preferably a Science or Engineering Degree, but not mandatory.
• Working knowledge of FDA 21 CFR part 210 and 211 requirements
• Minimum 3 years of experience in a cGMP environment.
• Minimum 3 years of experience with SAP, EQMS, and Autoscribe software
• Must be able to work with minimum supervision.
• Effective verbal / written communication, interpersonal, and team-building skills.
• Excellent organizational, problem-solving, prioritizing and follow-up skills.

• Ability to handle multiple tasks / projects simultaneously.
• Good computer skills. Proficiency with Microsoft Word, Excel, and Power Point.
• Knowledge of basic statistics

• Experience with FDA audits and any other 3rd party audits.
• ALCOA+ (Data Integrity) knowledge

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 the Quality Management Team.
  • Take necessary actions to correct or stop any unsafe conditions or practices.
  • Actively participate in safety meetings and training.
  • Review Material Data Sheet instructions before working with any chemical product

QUALITY ASSURANCE RESPONSBILITIES:

• • 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.

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.