Director, Quality Assurance
REQUIREMENTS: Must have at least a Master’s degree in Pharmaceutical Manufacturing or Pharmaceutical Science and 24 months of experience in a QA related role.
SPECIAL REQUIREMENTS: Must have documented experience in the following: Investigational product QA, validation, Minitab, FDA regulations, and quality audit.
JOB DUTIES: Ensure development and manufacture of drug products complies with internal and regulatory requirements. Specific duties include: Design, maintain and improve Quality Management System. Requires the Director of Quality assurance to establish the quality management system to describe how Elucida Oncology complies with GMP and operates to maintain a state of control. Write SOPs and update as needed to improve SOPs; Updates job knowledge by studying trends and developments in FDA regulations, current industry practices and quality management.; Develops quality assurance plans by conducting hazard analyses, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, monitoring inventories. Accomplish quality assurance HR, operational and financial objectives. Requires the employee to accomplish quality assurance human resource objectives by recruiting employees; communicating job expectations; reviewing job contributions and compensation; achieves quality assurance operational objectives by contributing information and analysis strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality and customer service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change and meet quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions. Oversee quality improvement, change control, deviation, out of specifications and CAPA. Requires the employee to validate quality processes by establishing product specifications and quality attributes; qualifying equipment; Maintains and improves product quality by conducting audits at Elucida Oncology or external CDMO; write audit reports and submit to Elucida management or External vendor, review manufacturing documents (SOPs, forms, Master Batch Record, Batch Production Record, QC results) as per Elucida policies and procedures. Review proposed changes and confirm that changes are implemented through change control, investigate deviations and out of specifications by performing root cause analysis and initiate corrective and preventive actions (CAPA) Ensures the integrity of data and operation at Elucida Oncology Requires the employee to Design, build and maintain database to store manufacturing and testing data, Prepare quality documentation and reports by collecting, analyzing and summarizing information and perform trending using MiniTab, develop and maintain training program, enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
CONTACT: Send resume to: Elucida Oncology Inc, 1 Deerpark Drive, Suite E, Monmouth Junction, NJ 08852
Jobsite: Monmouth Junction, NJ (Full-Time Position)