Quality Assurance Specialist

Duration: 6 Months

Responsibilities: Conducts Minor / Major / Critical Deviation investigations in their respective areas as necessary and documents such investigations appropriately Collects raw data and information needed to process the investigation Leads Root Cause Analysis to identify the most probable root cause, determine product impact, and assign appropriate CAPAs with responsibilities and due dates Performs trending to identify and report adverse trends that may require further action Writes the investigation report and completes investigations within the specified time-frames Develops corrective and preventative actions to prevent problem recurrence and establishes an effective follow-up system to ensure corrective and preventative actions have been implemented and are effective Manage client communications efficiently and effectively, to obtain timely approval of investigation reports Reports work progress and performance metrics to Project Leader on a daily and weekly basis

Requirements: Bachelor’s degree from an accredited college/university Appropriate written and verbal communication skills in English and in any other relevant language(s) +10 years of experience in Aseptic Processing facilities, with proven expertise in production deviation investigation and report writing Expert level understanding of deviation resolution for manufacturing processes and CAPA management Previous experience with remediation plans for the US FDA Expertise in other QA tasks that include PQR, auditing, change control, complaints management, OOS, batch record review, documentation management, training, supplier management) Collaborative team player with a strong focus on achieving KPIs and project goals while effectively navigating conflict and driving win-win resolutions