Senior Quality Assurance Specialist, Operations

Key Responsibilities

• Responsible for the quality release process for finished product distribution, including visual inspection of the finished product for the US market
• Manages temperature monitoring program for the distribution center, cold storage area and shipment of finished products
• Works with manufacturing sites to resolve quality issues such as consumer complaints, shipping and/or product storage conditions
• Reviews and approves artwork and rework instructions to ensure cGMP requirements are met
• Participates in multifunctional project teams to support the introduction of new products and/or changes to current products to ensure compliance with Quality System requirements
• Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies
• Provides guidance and control directives regarding remediation activities required to continue business operations
• Solves critical issues within the area assigned and may escalate to senior management team based on the severity of the problem
• Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of the monthly quality improvement meeting
• May be asked to lead process improvement initiatives
• May also attend, as a QA project team member, to provide QA guidance and oversight to such improvements
• Acts as backup for other personnel within QA

Skills & Qualifications

• Bachelor's degree required
• At least five to seven years of related experience in Quality Assurance within a regulated environment or transferrable industry experience
• Knowledge of applicable GXP regulations
• Working knowledge of applicable computer software
• Good organization and communication skills
• Good writing skills