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Quality Engineer

Location: 

Ormond Beach, FL, US

Req ID:  664
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

Edgewell Personal Care is looking to fill a Quality Engineer position for its manufacturing site located at Ormond Beach, Florida. The candidate should have an expert level knowledge of regulatory requirements pertaining to the validation processes necessary for OTC products. The candidate should have the necessary skill set to drive the lifecycle approach to validations.

 

 Universal Accountabilities

  • Ensure the quality of products produced at Playtex Business Unit is consistent with EPC/Playtex Mfg. Inc. Quality standards.
  • Ensure the Quality Unit is functioning efficiently by assessing current processes and identifying ways to streamline or improve.
  • Ensure the timely closure of Corrective Action Preventative Action (CAPA) investigations.
  • Ensure the timely closure of Change Requests (CR).
  • Ensure the timely completion of Validations.
  • Support Sun Care quality related projects; internal and external.
  • Communicates effectively with internal and external customers to resolve quality issues.
  • Creates reports for management, and other internal groups.  Reports include validation related protocols and reports, trip, audit, and status.  
  • Accountable to business needs to ensure minimal delay and cost to production.

 

Specific Accountabilities

  • Perform risk assessments to establish what type of validation methodology used.
  • Work with R&D to determine and maintain formula families as a risked based approach to validation.
  • Maintain validation matrix, validation log, and validation protocols for all formula validations.
  • Identify and perform verification studies on previously validated batches to adhere to lifecycle validation approach.
  • SME on formula validations. Point-of-contact for validations to FDA or other inspectors.
  • Write up validation protocols to document requirements for sample collection and testing.
  • Perform SPC statistical analysis of testing results to determine process capabilities.
  • Writing of validation executive summaries of formula validations.
  • Printing of batch cards during the validation process.
  • Proctoring of PQ batches to ensure quality and compliance as requested by operations.
  • Aid in investigations of compounding failures and deviations.
  • Work closely with other Quality engineers and R&D on APR and trending of in-process results.
  • Review data and identify adverse trends of analytical and microbial testing that may warrant R&D review.
  • Attend change control meetings for new formulations to ensure all tasks are being completed for new formulas to the plant.
  • Review new formula manuals to check for potential issues in specifications or manufacturability and compliance.
  • Review new formulation recipes for new chemicals being introduced to the plant and passing those new chemicals along to the safety board for review.
  • Review all batch cards for quality or compliance issues.
  • Stay informed on any changes to CFR or guidance documents from a process validation standpoint.
  • Review data for specification updates as required

 

Required Skills and Experience

  • Bachelor’s Degree in related field
  • Qualification/Validation experience desired
  • Five years minimum experience working in a manufacturing environment in a quality related field
  • Five years minimum experience in an FDA regulated business or ISO:9000 Quality System
  • ASQ certification preferred
  • QC laboratory knowledge preferred

 

 Preferred Skills and Experience

  • Knowledge of CFR 210/211 and/or CFR 820
  • Excellent communication skills, written and verbal
  • Excellent computer skills – Microsoft Office
  • Well organized person
  • Strong technical writing skills
  • Strong problem solving skills, including root cause analysis tools
  • Strong statistics and sampling plans background
  • Ability and willingness to travel, as in the execution of the duties of this position the employee may travel up to approximately 10%, or slightly more, of their work time

 

 Working Relationships

  • Position reports to a Quality Supervisor
  • Close relationships with Marketing, R&D, Packaging Development, Consumer Complaints, APR, Quality Engineering and Corporate Quality groups
  • External engagement may include Suppliers, Service Providers and Contract Manufacturers

 

 Work Environment

  • Ability to walk and stand for long periods of time (auditing)
  • Ability to travel – ground and air
  • Work schedules may vary from typical business hours
  • Exposure to health risks or conditions that may require the use of Personal Protective Equipment

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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.

 

 


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