Quality Control Associate I

Help us change lives

At Exact Sciences were helpingchange 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 purposedriven career an inclusive culture and robust benefits to support your life while youre working to help others.

Position Overview

The Quality Control Associate I will participate in a variety of Quality Control functions including but not limited to raw material inprocess material finished goods and stability testing support process and method development characterization and validation and quality documentation generation. This position may focus primarily on one or more of the following areas: Functional Testing; Analytical Testing; Stability Programs.

Essential Duties

Include but are not limited to the following:

• Analytical and functional testing of raw materials intermediates and finished goods in support of R&D process and product characterization the Validation Program Stability Quality Control and troubleshooting efforts.
• Routinely perform analytical and functional techniques associated with oligonucleotides enzymes antibodies standard molecular biology reagents and complex molecular diagnostics.
• Participate in Out of Specification and NCMR Deviation report generation and CAPA efforts.
• Execute protocols supporting Process Test Method Validation and Stability Studies in accordance with internal procedures cGMPs FDA and ICH guidelines.
• Support drafting and reviewing quality documents including but not limited to Standard Operating Procedures and raw material specifications that are compliant with cGMP/GLP guidelines.
• Provide support in cross functional teams as required.
• Support the Operations department in other nonlaboratory functions as determined by Operations management.
• Supports laboratory stocking and cleaning.
• Performs peer review for work done within the department.
• Support and comply with the companys safety and environmental procedures.
• Evidence of strong analytical and problemsolving skills and ability to make decisions with supported information and direction.
• Pay strong attentiontodetail necessary in a GMP environment.
• Strong knowledge of Microsoft Office programs such as Word Excel and PowerPoint.
• Ability to work effectively in team situations as well as independently.
• Excellent oral and written communication and interpersonal skills.
• Ability to learn laboratory techniques.
• Ability to follow procedures or experimental plans.
• Ability to work in a fast paced ever changing environment.
• Uphold company mission and values through accountability innovation integrity quality and teamwork.
• Support and comply with the companys 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 seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.
• Ability to lift up to 40 pounds for approximately 5% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment for extended periods of time.
• May perform repetitious actions using lab tools.
• 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 highspeed centrifugation.
• Ability and means to travel between local Exact Sciences Madison locations.

Minimum Qualifications

• Bachelors degree in chemistry Molecular Biology or a science related field; or Associates Degree and 2 years of relevant experience in lieu of Bachelors Degree.
• 1 years of experience using laboratory equipment and modern laboratory techniques in a Biotechnology field or clinical setting.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Strong documentation skills in accordance with GMP requirements.
• Familiarity with databases spreadsheets and statistical programs.
• Experience in a GMP and/or ISO13485 environment.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation holidays volunteering and personal time) paid leave for parents and caregivers a retirement savings plan wellness support and health benefits including medical prescription drug dental and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation please contact us here.

Not ready to apply Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability protected veteran status and any other status protected by applicable local state or federal law.

To view the Right to Work EVerify Employer and Pay Transparency notices and Federal Federal Contractor and State employment law posters visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.