QA Specialist (Batch Records)

Quanterix

Billerica, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Post Date: 02/17/2021
  • Website: quanterix.com
  • Company Address: One Kendall Square Building 1400, Cambridge, MA, 02139

About Quanterix

Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease.

Job Description

To continue our solid growth, we are seeking a talented and highly motivated individual to support our efforts in the batch record area within our Quality Assurance team.  The Quality Assurance  Specialist – Batch Records will support the Quality Assurance Specialist by assisting in the processing of batch control records, including providing the QA review of completed component forms, archiving and filing the final batch records and other company records.

Key Responsibilities:

Support the Quality Assurance Specialist in:

  • Reviewing/scanning/closing batch record related documents,
  • marking documents for corrections and interfacing with Manufacturing/QC to implement corrections,
  • Performing kit lot releases and posting assay documentation on website,
  • Issuing, reviewing, and closing batch record-related deviations,
  • Supporting metric reporting,
  • Filing batch records and maintaining physical/electronic archives,
  • Filing general records, and
  • Preparing inventory for offsite storage.

Skill and Knowledge Requirements:

  • Demonstrated superior communication skills.
  • Excellent organizational and time management skills.
  • Solid work ethic and a superior attention to detail.
  • Excellent written and editorial skills.
  • Demonstrated strength working independently.
  • Excellent team player with strong interpersonal skills.
  • Experience working in a regulated environment (ISO, GLP, GMP, FDA) strongly preferred.
  • Working knowledge of Microsoft Word and Excel is required
  • Demonstrated ability maintaining multiple deadlines.

 

Minimum Experience and Education:

  • Bachelor’s degree in Science, Medical Technology, English, or Technical Communications.
  • 1+ years of Quality Assurance and/or batch record experience preferred.

Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.

Quanterix is committed to a diverse and inclusive workplace. Quanterix is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.