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Quality Control Associate I

Company

Exact Sciences Corporation
Address , Madison, 53719, Wi
Employment type FULL_TIME
Salary $41,000 - $66,000 a year
Expires 2023-07-21
Posted at 11 months ago
Job Description
Position Overview
The Quality Control Associate I will participate in a variety of Quality Control functions, including but not limited to, raw material, in-process material and finished goods testing; process and method development, characterization and validation, and quality documentation generation. The 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:
  • Ability to travel approximately 5% of working time.
  • Ability to use and wear safety protective gear/equipment (e.g. safety glasses, lab coat, gloves, respirator, etc.) and follow safety guidelines while in the lab, etc.
  • Ability to work at a laboratory bench or fume hood for extended periods of time.
  • Execute protocols supporting Process and Test Method Validation efforts in accordance with internal procedures, cGMPs, FDA, and ICH guidelines.
  • Ability to follow procedures or experimental plans.
  • Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
  • Ability to work designated schedule.
  • Excellent oral and written communication and interpersonal skills.
  • Perform other related duties as assigned by management.
  • Ability to lift up to 50 pounds for approximately 5% of a typical working day.
  • Strong attention-to-detail necessary in a GMP environment.
  • Routinely perform analytical and functional techniques associated with oligonucleotides, enzymes, antibodies, standard molecular biology reagents, and complex molecular diagnostics.
  • Ability and means to travel between Madison locations.
  • Support the Operations department in other non-laboratory functions, as determined by Operations management.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Participate in drafting and review of quality documents, including but not limited to, Standard Operating Procedures and raw material specifications that are compliant with cGMP/GLP guidelines.
  • Participates in Out of Specification and customer complaint investigations, Deviation report generation and CAPA efforts.
  • Constant walking or motion to coordinate work and interact with co-workers.
  • Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
  • Proven ability to work effectively in team situations as well as independently.
  • Analytical and functional testing of raw materials, intermediates and finished goods in support of R&D, process and product characterization, the Validation Program, Quality Control and troubleshooting efforts.
  • Ability to work with hazardous or flammable materials (e.g. chemicals, radioactivity, electrical equipment) so as not to endanger oneself or others.
  • Provide support in cross functional teams, as required.
  • Ability to utilize lab equipment for up to 6 hours per day (includes pipetting, etc.)
  • Support and comply with the company's safety and environmental procedures.
  • Regular and reliable attendance.
  • Ability to sit for an extended period of time.
  • Evidence of strong analytical and problem-solving skills, and ability to make decisions with limited information and operate with autonomy.
  • Assist in the scheduling of laboratory activities.
  • Regularly sets up, adjusts, assembles, controls, tests, positions and operates objects and equipment weighing up to 20 pounds.
  • Ability to stand for extended periods of time and up to 6 hours at a time.

Minimum Qualifications
  • Experience in using basic software applications including Microsoft Office.
  • Understanding in modern analytical techniques such as HPLC, UV/VIS Spectroscopy, PCR and ELISAs and their applications.
  • Bachelor’s degree in Chemistry, Molecular Biology, Biochemistry or related field.
  • 1+ years of experience using laboratory equipment supporting Molecular Biology workflows.
  • Authorization to work in the United States without sponsorship.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Preferred Qualifications
  • Familiarity with database, spreadsheets, and statistical programs.
  • Internship experience in a life sciences environment.
  • Experience in complex molecular biology or analytical chemistry techniques.
  • Strong documentation skills in accordance with GMP requirements.
  • Experience in a GMP and/or ISO13485 environment.
#LI-HE1
Salary Range:
$41,000.00 - $66,000.00
The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms, conditions, and eligibility requirements of the applicable plans.
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 email .
We are 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. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
To view the Right to Work, E-Verify Employer, and Pay Transparency notices refer to
this link
. These notices inform you of your rights protected by the Office of Federal Contract Compliance Programs (OFCCP).