EXO QA Specialist
Coty Inc. - Sanford, NC

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JOB DESCRIPTION

TITLE

Quality Assurance Specialist -A

FUNCTION

Quality Assurance External Operation

REPORTING TO

Quality Assurance Director, ExO

N° OF REPORT

n/a

PURPOSE OF THE ROLE

TO ASSESS THE LEVEL OF QUALITY AND GOOD MANUFACTURING PRACTICES ACROSS ALL THIRD PARTY MANUFACTURERS FOR COMPLIANCE WITH COMPANY STANDARDS, REGULATORY REQUIREMENTS AND BUSINESS NEEDS.

TO PERFORM QUALITY CONTROL (QC) INSPECTION ON FINISHED PRODUCT TO ENSURE COMPLIANCE WITH PRODUCT SPECIFICATIONS WHEN REQUIRED, AND PREVENT POOR QUALITY PRODUUCTS FROM ENDING UP ON THE MARKETS

TO LEAD INVESTIGATION AND FOLLOW UP OF CORRECTIVE AND PREVENTIVE ACTIONS FOR ANY PRODUCT NON CONFORMANCE TO AVOID RECURRENCES.

MAIN INTERFACES

INTERNALLY:
  • QUALITY ASSURANCE
  • QUALITY CONTROL
  • TECHNICAL PACKAGING DEVELOPMENT
  • PACKAGING CONCEPT DEVELOPMENT
  • RESEARCH & DEVELOPMENT
  • PROCUREMENT
  • PLANNING

EXTERNALLY:
  • THIRD PARTY MANUFACTURING
  • EXTERNAL SERVICE PROVIDERS (LABS, CONSULTANTS, INSPECTORS)

KEY TASKS AND RESPONSIBILITIES

ACCOUNTABILITY AREA
  • TO PROVIDE RELIABLE AND TIMELY ASSESSMENT OF THE LEVEL OF GMP COMPLIANCE OF QUALITY SYSTEMS, PROCESSES, TOOLS AND RESOURCES OF TPM
  • TO INFORM MANAGEMENT OF ANY CRITICAL AUDIT FINDING OR PRODUCT OUT OF SPECIFICATION IN A TIMELY AND EXPERT MANNER
  • TO PROVIDE RELIABLE AND TIMELY ASSESSMENT OF THE LEVEL OF COMPLIANCE OF PRODUCTS AGAINST EXTERNAL AND INTERNAL REQUIREMENTS, INCLUDING OTC

FUNCTIONAL TASKS
  • TO EXECUTE TPM AND INTERNAL AUDITS AS PER APPROVED PLAN
  • TO ISSUE AUDIT REPORTS IN A TIMELY AND EXPERT MANNER
  • TO ENSURE ISSUANCE OF CAPA PLANS AND IMPLEMENTATION AND COMPLETION THEREOF UNTIL CLOSE-OUT.
  • TO PERFORM QC INSPECTION OF PRODUCTS IN SUPPORT ROLE AS NEEDED
  • TO REPORT AND INVESTIGATE ANY PRODUCT NON CONFORMANCE
  • TO ACT AS SINGLE POINT OF CONTACT WITH TPM FOR ANY QUALITY AND COMPLAINCE TROUBLESHOOTING ON COTY PRODUCTS
  • TO ANALYSE PRODUCT COMPLAINTS AND ENSURE RCA IS PERFORMED WITH TPM; MONITOR MONTHLY COMPLAINTS PROGRAM WITH TECHNICAL DIRECTOR AND QA
  • TO COLLECT AND ANALYSE KPI AS REPORTED IN THE QA AND PKG SCORECARDS
  • TO PROVIDE SUPPORT IN THE FIELD OF TECHNICAL EXPERTISE TO OTHER QA AND PACKAGING FUNCTIONS TO ACHIEVE THE COMPANY OBJECTIVES
  • TO WRITE INITIAL DRAFT OF SOP’S IN ETQ FOR QA DEPARTMENT
  • TO PROVIDE TRAINING ON SOP’S AND MAINTAIN DEPARTMENTAL DOCUMENTS

EXPERTISE AND SKILLS

BUSINESS EXPERTISE
  • HAVE THE EXPERTISE TO ASSESS A UNIFORM APPLICATION OF QUALITY MANAGEMENT SYSTEMS AND PROCESSES ARE IN PLACE TO ALLOW ACHIEVEMENT OF GMP COMPLIANCE, EFFECTIVENESS AND IMPROVEMENT
  • HAVE THE EXPERTISE TO ANALYZE AND UNDERSTAND THE COSMETIC AND OTC INDUSTRY AND REGULATORY CHANGES AND TRENDS TO PROVIDE QUALITY ASSESSMENT OF THE MANNER IN WHICH TPMs RESPOND TO NEW REQUIREMENTS
  • HAVE THE EXPERTISE TO PROVIDE GMP COMPLIANCE ASSESSMENT TO FUCNTIONS WITHIN THE COMPANY IN ORDER FOR THEM TO DEVELOP OR SUPPORT THE DEVELOPMENT AND SUPPLY OF PRODUCTS IN A TIMELY FASHION, MEETING QUALITY AND MARKET REQUIREMENTS.

PROBLEM SOLVING
  • HAVE THE ABILITY TO ASSESS AND HIGHLIGHT AREAS OF IMPROVEMENTS BASED ON A SOLID BACKGROUND AND UNDERSTANDING OF GMP INDUSTRY STANDARDS AND REGULATORY REQUIREMENTS
  • HAVE THE ABILITY TO ANALYZE NON CONFORMANCE AND UNDERSTAND THE ROOT CAUSE TO PROVIDE CLEAR GUIDANCE FOR RESOLUTION.

INTERPERSONAL SKILL
  • ESTABLISH POSITIVE INTERACTIONS WITH AUDITEE AND THEIR MANAGEMENT IN ORDER TO FOSTER EFFECTIVE AND TIMELY CORRECTIVE AND PREVENTIVE ACTION PLAN
  • PERFORM AUDIT WITH ASSERTIVENESS, DIPLOMACY AND EXPERTISE
  • ABILITY TO INTERACT CONSTRUCTIVELY WITH ALL FUNCTIONS AND MULTIPLE PERSONNEL LEVELS WITHIN THE COMPANY
  • STRONG VERBAL AND WRITTEN COMMUNICATION SKILLS; MICROSOFT OFFICE, VISISO, DATABASE, SAP AND WMS FAMILIARITY DESIRED
CANDIDATE’S PROFILE

EDUCATION/PROFESSIONAL EXPERIENCE
  • BACHOLARS DEGREE AT A MINIMUM, AUDITING CERTIFICATION A PLUS
  • MINIMUM 5 YEAR EXPERIENCE IN COSMETIC OR PHARMACEUTICAL INDUSTRY SPECIFICALLY IN GMP QUALITY ASSURANCE
  • DEMONSTRATED SUCCESS RECORD AS QUALITY AUDITOR
  • SOUND AWARENESS AND UNDERSTANDING OF OTC AND COSMETIC BUSINESS, AND US LEGAL REQUIREMENT, KNOWLEDGE OF EU ISO 22716 A PLUS.

LANGUAGES
  • FLUENT IN ENGLISH, BOTH SPOKEN AND WRITTEN

SKILLS & COMPETENCIES
  • DIPLOMACY AND STRONG INFLUENCING SKILLS
  • EXCELLENT CONFLICT AND CRISIS MANAGEMENT SKILS
  • EXCELLENT EFFICIENCY AND TIME MANAGEMENT SKILLS
  • STRONG PEOPLE MANAGEMENT SKILLS
  • STRONG RESULTS ORIENTATION
  • HIGH ETHICAL STANDARDS AND DISCRETION

OTHERS
  • FLEXIBILITY AND DISCRETION
  • AVAILABILITY TO TRAVEL 30 % OF THE TIME

Coty Inc. - 20 months ago - save job - block
About this company
Sarah Jessica Parker, Beyoncé, and Jennifer Lopez are just a few of the celebs to promote Coty. It is one of the world's leading makers...