Quality Systems Specialist

Recruiter
West Pharmaceutical Services
Employment Type
Permanent
Salary
Not disclosed
West Pharmaceutical Services logo

Job Summary:

The Supplier Quality Specialist is responsible performing Supplier Quality activities associated with external suppliers.  This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies outlined in the Supplier Quality Management program. This position responsible for managing the following supplier management tools and processes to ensure compliance to standards and processes: – Performance metrics (scorecard) – Supplier Corrective Actions- Change Requests- Profiles- Certifications – Approved Supplier List- Perform supplier Audits and record Management.  This role interfaces with R&D, Sourcing, Global Quality & Regulatory and Operations to drive improved supplier quality performance. Other activities may include, but are not limited to, tracking supplier performance, coordinating with West procurement teams on supplier improvement efforts, and driving quality improvement initiatives

Essential Duties and Responsibilities:

  • Establish and successfully execute supplier management plans which will align to overall business objectives
  • Ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and Regulatory requirements are met
  • Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation
  • Identify potential risks before they become a problem, focusing on root cause analysis and preventive action
  • Perform assigned quality systems and processes audits at supplier sites which provide materials, components, sub-assemblies, and services.
  • Analyze and support the resolution of complex manufacturing and compliance issues at supplier sites
  • Collect and analyze quality metrics relating to supplier quality
  • Act as a subject matter expert in key technical areas
  • Communicate supplier quality risks to upper management identifying solutions to mitigate risks
  • Maintain approved supplier list and supplier records in accordance with quality processes 
  • Participate on project teams for supplier selection activities and supplier risk management
  • Participates in supplier performance reviews and quality review meetings, as needed
  • Participates in the development of measurable KPIs and supplier quality scorecards to track and trend supplier performance 
  • Train and ensure all assigned employees are aware of and comply with company policies, government procedures, and regulations.
  • Provides guidance to cross functional teams in applying supplier quality system requirements
  • Summarizes outputs, with guidance, from supplier quality management activities for organizational communication and input into management review.
  • Performs other duties as required

Basic Qualifications: 

  • Education: Bachelor or Master’s degree in science preferred or equivalent experience in related discipline 
  • Experience: Minimum three (3) years of Quality related experience. 

Preferred Knowledge, Skills and Abilities:

  • Understands interpretation and application of quality standards in a regulated environment (ISO, GMP, etc.)
  • Working knowledge of Pharmaceutical Industry requirements for elastomeric closures and medical devices.
  • Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams.
  • Use written and oral communication skills
  • Read and interpret data, information, and documents. 
  • Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations 
  • Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
  • Excellent organizational skills with an ability to think proactively and prioritize work.
  • Working knowledge of statistical data analysis
  • Thorough understanding of risk management principles and techniques
  • Strong problem-solving and critical thinking skills
  • Medical industry or highly regulated industry
  • Project Management experience
  • Familiarity with document management databases, particularly MasterControl. 

Travel Requirements:

  • Must be able to travel up to 20-25% of the time, as needed 

Physical & Mental Requirements:

  • Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making. Excellent written and oral communication skills
  • Ability to work in an office and/or manufacturing environment. May need to stand or sit for extended periods of time
  • Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
  • Read and interpret data, information and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Demonstrates enthusiasm, takes accountability and drives for results.