Sr Specialist, QA

Salary depends on experience
Posted on 11/03/17
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 11/03/17

PRIMARY DUTIES AND RESPONSIBILITIES: 

  • Provides support to Quality group ensuring consistent application of quality techniques
  • Leads and manages key projects/initiatives related to Quality and ensures that progress is within expected guidelines and timelines.
  • As the point of contact on assigned projects, performs a variety of highly skilled duties such as assembling, coordinating and managing multidisciplinary technical review teams.
  • Provides technical and management advice and assistance to department management and personnel.
  • Coordinates and manages day-to-day operations and communications with client and internal departments to ensure all elements are in spec and launch on schedule.
  • Creates a detailed work plan which identifies and sequences the activities needed to successfully complete a project.
  • Develops a schedule for project completion that effectively allocates the resources to the activities.
  • Review the quality of work completed with the project team  to ensure it meets project standards.
  • Ensure that the project and work deliverables are on time, within budget and at the required level of quality.
  • Identifies and determines quality improvement
  • Establishes statistical confidence by identifying sample size and acceptable error
  • Develops sampling plans by applying attributes
  • Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
  • Prepares reports by collecting, analyzing and summarizing data; makes recommendations
  • Aids in maintaining Quality systems and other communication tools for Quality group
  • Identify application opportunities for the technical/statistical tools of quality/process improvement
  • Provide process improvement know how, methods and conceptual expertise to teams.
  • Performs other duties as assigned based on business needs.
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
  • Exhibits regular, reliable, punctual and predictable attendance.

REQUIRED QUALIFICATIONS: 

  • Education: Bachelor’s or equivalent work experience
  • Experience: 5-8years of experience in Quality or Project Management related field
  • Attention for detail and deadline driven
  • Ability to work independently, multi-task and thrive in fast-paced environment
  • A sense of urgency/initiative
  • Superior organizational and leadership skills with ability to help team grow and thrive
  • Demonstrate team building and problem solving skills
  • Professional communication and presence
  • Knowledge of cGMP requirements and ISO standards
  • Ability to effectively prioritize and escalate issues
  • Excellent implementation and customer service skills

PREFERRED QUALIFICATIONS: 

  • Product related knowledge and experience
  • Experience in an analytical role
  • 13485 Lead Auditor Certification or ASQ CQA

6485

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