Quality Assurance Specialist

Location
07059, Warren
Posted
Feb 18, 2021
Ref
35737
Discipline
Quality
Required Education
Bachelors Degree
Position Type
Contract

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading Pharmaceutical company is hiring a Quality Assurance Specialist on a contracting basis.

Work Location: Warren NJ

Summary:

  • Responsible for quality and disposition activities
  • Functional responsibilities include performing incoming material release and product release, as needed, ensuring accurate and timely maintenance and review of manufacturing batch record documentation, On-Site coverage/participation in QA Shop Floor activities, and performing document issuance for manufacturing
  • Participate in QA shop floor program
  • Issue production batch records and product labels to Operations
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
  • Must be skilled in planning and organizing, decision-making, and building relationships
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
  • Revise department SOPs
  • Real time review and approval of executed batch records
  • Responsible for Material Status Changes of production/drug product materials

Required skills:

  • Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance
  • Bachelor’s Degree Required, Science related degree preferred
  • Minimum of four to five years of related Quality Assurance experience in the pharmaceutical industry required
  • Strong knowledge of cGMP principles required
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions
  • Seeks management guidance on complex issues
  • Develops procedures
  • Proposes solutions for complex issues and works with management to resolve
  • Follows established procedures and performs work as assigned
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
  • Is recognized Subject Matter Expert within the group
  • Provides guidance to other employees in interpretation of complex data
  • Understands continuous improvement and improves efficiency and productivity within the group or project

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