Job Title: Quality Assurance Manufacturing Specialist
Direct Manager Title: Quality Control Manager
To provide Quality support for floor level operations in the manufacturing department. Through daily batch record review, auditing and continuous improvement activities drive quality Key Performance Indicators to exceed both plant and corporate targets. Ensure appropriate procedures are in place and utilized for daily operations on the manufacturing floor and assist Operations in investigations and RCPS events to identify and eliminate systemic issues.
Responsible for continued implementation on GMP requirements.
Responsible for enforcement of safety procedures, maintaining tool calibration, work organization and overall cleanliness of the assigned work area.
Auditing of documentation, processes and faculties to ensure compliance with GMP’s and Coty policies and procedures.
Help identify and resolve Manufacturing related issues that negatively impact KPI’s (Bulk RFT, QA Index)
Responsible for timely execution of Validation Protocols and Final Reports.
Documents local processes in ETQ (SOPs, Work Instructions, One Point Lessons)
Applies proficient computer skills in the use of Microsoft Office suite and database applications such as Oracle, DM+, SAP and MS Access.
Participate in project teams (as applicable) to effectively manage changes resulting in the improvement of material/product quality and/or processes.
May be required to provide some technical training to employees.
Implement. Oversee, and Manage Good Laboratory Practices (GLP).
Assists in developing procedures to ensure regulatory compliance through the QA Index
Perform critical review of supporting quality assurance documentation for both content and format
Assist operating units during internal audits, status review, government audits, etc.
Act as a validation and change management/control expert and train Engineering, Manufacturing, Quality and R&D representatives on Validation and Change Management requirements
Act as a project leader for Quality Management Systems tools implementation
Drive 5S program within the Quality team
Assist with Raw Material Supplier Management and Quality Control activities as required.
VI. KEY INDICATORS:
Zero safety infractions (No incidents, No Injuries, No violations of established policies or procedures)
5S Compliance (Daily Checklist, Weekly Audit)
Bulk RFT – Right the First Time (%)
KNOWLEDGE (Process or Function)
GMP’s, GLP’s and GDP’s
Practical application of ANSI/MIL-STD tools
Root cause problem solving capability
Use of standard lab measurement equipment and tools
Handling internal and external audits
Read and interpret specifications with tolerances
Experience and use of GLPs, GMPs, specifically 21 CFR parts 210, 211
Experience in validation, quality control, quality assurance, and/or production applications.
Preferred 5+ years’ experience in a regulated manufacturing environment.
Lean or six sigma experience preferred
Strong interpersonal skills
Ability to develop and express ideas
Strong communication skills (verbal and written)
Work in a team-based environment (shared ownership and responsibility)
Coaching of tools, processes, and systems to associates
Strong time management discipline
Good computer skills (Word, Excel, Powerpoint, EtQ, DM+, Oracle, QMIS)
Pursue aggressive elimination of waste and champion for continuous improvement
Process rigor – drive standardization, reliability, and consistency
Drives reapplication and benchmarking
Responsiveness to changing business conditions and customer needs
Success through teamwork
Questioning and challenging
Displays initiative without external motivation (drive for results)
Two years work experience in a Quality inspection/auditing role in pharmaceutical ,cosmetics or FMCG environment preferred. Basic mathematical skills. (Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.)
2 years associate degree preferred.
High School diploma or GED required.
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