Supervisor, Quality Control

Help us change lives

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Supervisor, Quality Control will supervise, lead, train and assist the QC team in a variety of QC functions including, but not limited to, raw material, in-process material, finished goods and stability testing, process and method development, characterization and validation, and quality document generation. This position will be responsible for equipping, scheduling, and establishing systems for QC functions working closely with other Quality Control management and coordinating efforts. 

Essential Duties

Include, but are not limited to, the following:

• Supervise the analytical and functional testing of raw materials, intermediates and finished goods in support of R&D, product and process characterization, the validation program, quality control, stability and troubleshooting efforts.
• Supervise, lead, develop, qualify, troubleshoot and routinely perform analytical and functional techniques associated with oligonucleotides, enzymes, antibodies, standard molecular biology reagents, and complex molecular diagnostics.
• Provide subject matter expertise for the Quality Control team in Out of Specification and NCMR resolution, Deviation report generation and CAPA efforts.
• Draft and/or review protocols supporting Process Validation, Test Method Validation, and Stability Studies in accordance with internal procedures, cGMPs, FDA, and ICH guidelines.
• Write and review quality documents including, but not limited to, Standard Operating Procedures and test and inspection methods that are compliant with cGMP/GLP guidelines.
• Provide representation or lead support of cross functional teams and process improvements.
• Lead project activities associated with or supported by QC.
• Evidence of strong analytical and problem-solving skills, ability to make decisions with limited information and operate with autonomy.
• Strong documentation, attention-to-detail and procedure writing skills suitable for a GMP environment.
• Ability to interpret technical data and present findings to management.
• Demonstrated ability to develop/transfer and thoroughly document new processes and production procedures.
• Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assessing employee performance and providing helpful feedback and training opportunities.
• Consistent demonstration of exceptional leadership qualities including, but not limited to, the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.   
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment; some for extended periods of time while performing repetitious actions.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability and means to travel 10% between Exact Sciences locations.
• May include overnight/weekend travel away from home location.

Minimum Qualifications

• Bachelor’s degree in Chemistry, Molecular Biology or a science related field as outlined in the essential duties; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience as outlined in the essential duties in lieu of bachelor’s degree.
• 6+ years of experience using laboratory equipment and modern laboratory techniques in a Biotechnology field.
• 3+ years of experience in a GMP/ ISO13485 laboratory environment and strong documentation skills in accordance with GMP requirements.
• Proficient in Microsoft Office, such as Word, Excel, PowerPoint, Outlook, as well as working knowledge with database, spreadsheets, and statistical programs.
• Profes