Senior Quality Assurance Engineer

Summary of Major Responsibilities

The Senior Quality Assurance Engineer will provide support to the Operations for a variety of functions, including process validation, facility validation, test method validation, process risk management and applied statistical analysis. The position will work within defined protocols and procedures and may lead or assist in developing and documenting new procedures for Operations relating to validation.  The position will also provide Operations support for the day-to-day activities such as investigation support and material release.

Essential Duties and Responsibilities

  • Assist the validation project lead and operations manager in project management and status updates for ongoing activities.
  • Work with and provide support to Operations personnel in the completion of validation efforts for process, test method, and facility qualification/validation.
  • Review and approve documents prepared by other team members and Operations.
  • Provide Operations support for investigations and material release.
  • Participate in FMEA process risk assessments.
  • Implement processes to monitor product and process performance, compliance and reliability.
  • Implement, conduct and report on process quality programs using statistical data analysis.
  • Participate as a Quality representative on design transfer and process improvement projects.
  • Generate, prepare and issue data for assigned quality reports.
  • Participate and provide Quality perspective for scale up activities including validation requirements.
  • Perform other related duties as assigned by management.

Qualifications

Mandatory Skills

  • Proven ability to lead and work effectively with and through multi-functional teams to achieve results.
  • Position requires an intermediate level of applied statistics skills used for scientific data analysis.
  • Excellent interpersonal skills with the ability to collaborate closely with Operations staff at varying levels to drive compliance and operational excellence.
  • Knowledge and experience working within an CFR 820, ISO 13485, ISO 9001 and/or cGMP structured environment
  • Excellent oral and written communication skills.

Education and Experience

  • Bachelor’s degree in an engineering or science field with focus on Biology and/or Chemistry, or related field with the equivalent combination of education and experience.
  • 5 or more years’ experience in a manufacturing operation environment.
  • 3 or more years’ experience in Process Validation principles and practice.

Preferred Qualifications

  • 5 or more years’ experience in a biotech manufacturing environment, preferably in a GMP and/or ISO13485 environment.
  • Bachelor’s degree in Engineering or Science field
  • Experience with Project Management principles and practice
  • Demonstrated experience in Validation Projects in a GMP environment
  • Demonstrated experience in support of Facility expansion and qualification

Physical Requirements

  • Ability to use computers daily in an interactive manner for extended periods of time.
  • Ability to sit for an extended period of time.
  • Ability to frequently and accurately communicate with employees in person, via the telephone or by email

EEO Disclosure

Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request. 

If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please call our Recruitment Coordinator at 608-535-8841 or email [email protected].


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