Quality Assurance Specialist in Summit, NJ at Pyramid Consulting, Inc

Date Posted: 1/13/2020

Job Snapshot

Job Description

Immediate need for a talented Quality Assurance Specialist  with experience in the Pharmaceuticals Industry. This is a 12+ Months Contract opportunity with long-term potential and is located in Summit, NJ. Please review the job description below.
 
Job ID: 20-01717

Key Requirements and Technology Experience:
  • Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
  • 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.
  • Must possess an independent mindset.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
  • Work is self-directed.
  • Confident in making decisions for non-routine issues.
  • 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.
  • Understands continuous improvement and improves efficiency and productivity within the group or project.
  • Builds relationships internally within and with cross functional teams.
  • Contributes to goals within the work group.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to effectively multi-task.
  • Knowledge of US and global cGMP requirements.
  • Excellent verbal and written communication skills.
  • Perform QA shop floor activities.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Perform real time review of manufacturing batch records.
  • Review manufacturing shop floor documentation.
  • 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.
  • Able to effectively multi-task.
Our client is a leading Pharmaceuticals Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. J2W:CB3