Quality Assurance Specialist

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