Sr. Scientist, Quality Control - Remote

Overview

The Quality Control Sr. Engineer (Scientist) provides test method and qualification support along with implementation of new processes, instrumentation, cost savings, and continuous improvements. The position will support the required action steps and process improvements to meet Biologics requirements. The position will ensure QC lab complies with applicable standards and regulations and partner with various APC and/or corporate departments to complete required testing and documentation.

In Short

• Drive completion of OOS investigations and deviations for QC.
• Develop protocols for projects such as method improvements.
• Partner with QC Lab Management on ongoing and new process improvements.
• Direct the completion of Qualification and Re-Qualification requirements for QC Lab Instrumentation.
• Manage Commercial stability studies and coordination of sample testing.
• Lead and participate in BLA support including PAI action steps.
• Define and implement automation and new capital projects.
• Prepares reports and presentations by collecting, analyzing, and summarizing data.
• Lead Quality Control issue resolution by applying root cause methodologies.
• Participate in FDA inspections and internal audits.

Requirements

• Bachelor’s degree in chemistry/biology, or closely related field.
• 5+ years’ experience in Quality Control laboratory, R&D Laboratory, or Quality Engineering.
• Understanding of quality control instrumentation and testing methods.
• Problem solving using root cause methodologies including lean principles.
• Applying statistics and software in data analysis (example Minitab).
• Quality system regulations and requirements.
• Six Sigma Green/Black Belt preferred.

Benefits

• Comprehensive, high-quality benefits package effective on date of hire.
• Educational assistance available for all employees.
• Matching 401(k) retirement plan.
• Flexible working hours.
• Paid holidays, including floating holidays.
• Employee Stock Purchase Plan.
• Referral incentive program.