Job Details

  • Title: Quality Assurance Manager
  • Code: RCI-7746
  • Location: West Greenwich Rhode Island (RI) 02817
  • Posted Date: 10/02/2020
  • Duration: 12 Months
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  Job Description

In support of Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility

  • Act as reviewer and approver for operational SOP’s and Work Instructions
  • Review of operational SOP’s and Work Instructions
  • Review and approve change controls and class I Non Conformances
  • Initiate and own QA Non Conformances as needed
  • Review and approve System Life Cycle Documents (i.e. test protocols) before use in production
  • Initiate, execute, and track completion of Change Control and Non Conformance requests related to computer systems
  • Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
    • Qualitative information
    • Quantitative research
    • Trend data
  • Forecasts, models and utilizes advanced analytical tools
  • Anticipates and prevents potential problems
  • May be responsible for specific programs and/or projects
FUNCTIONS
  • Responsible for hiring, training, supervising and performance management of staff
  • May perform or oversee the following functions:
    • Review and approve product MPs
    • Approve process validation protocols and reports for Mfg. processes
    • Approve Environmental Characterization reports
    • Approve planned incidents
    • Represent QA on NPI team
    • Lead investigations
    • Lead plant audits, participate in site audits
    • Approve change-over completion
    • May perform work of QA Specialist
EDUCATION/LICENSES
  • Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience
  • Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
COMPETENCIES/SKILLS
  • Project management skills
  • 5+ years of QA with emphasis of computerized system validation
  • Must have QA experience, Compliance experience, & Computerized system validation
  • Pharma & Biotech experience must have
  • Strong organizational skills, including ability to follow assignments through to completion
  • Initiate and lead cross functional teams
  • Collaborate and communicate with higher level outside resources
  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development
  • Strong communication (both written and oral), facilitation, and presentation skills
  • Strong skill in working independently and to effectively interact with various levels
  • Ability to lead and influence staff outside own organization
  • Ability to motivate staff and manage and distribute workloads
  • Able to manage performance issues and conflict
  • Ability to provide direction and establish goals for individual staff members and work group
  • Ability to evaluate documentation/ operations according to company and regulatory guidelines
  • Ability to interact with regulatory agencies
  • Demonstrate the Values/Leadership Practices