INACTIVE
Full-Time
Production Test Specialist
Posted on 4/3/2024
Ultra-sensitive biomarker detection technology
Data & Analytics
Mid
Billerica, MA, USA
Requirements
- Bachelor's Degree in Chemistry/Biochemistry/Biology/related field; or Scientific Associate Degree with additional years of life science experience
- 1+ years of QC analytical experience working within the medical device or pharmaceuticals regulated product environment preferred
- Familiarity with application of FDA and/or ISO quality standards in a government regulated industry preferred
- ELISA's and other plate-based methods for routine and non-routine use experience preferred
- Exposure to creation of QC documents and quality events
- Working knowledge of standard laboratory practices and safety
- Microbiology experience preferred but not required
- Preferred to have hands-on experience and demonstrated organisational skills in a regulated analytical environment
- Demonstrated ability to work well within cross-functional teams as a team player
- Possess an ability to learn and master complicated concepts quickly and comfortably
- Ability to generate high quality data under tight deadlines, and a collaborative, proactive attitude
- Strong attention to detail
- Strong computer and database skills
Responsibilities
- Perform bioburden testing on samples from manufacturing, documenting and reporting results
- Work with quality assurance to develop AQL sampling plan for bioburden testing
- Develop and maintain standard operating procedures and work instructions for performing bioburden testing
- Perform maintenance and cleaning of equipment used for bioburden testing
- Perform/manage daily, weekly, monthly instrument maintenance and cleaning
- Perform immunoassay testing on automated and semi-automated instrument platforms
- Perform peer review/approval of test data
Quanterix specializes in Simoa technology, a forefront in ultrasensitive biomarker detection for early disease diagnosis and precise treatment across areas like oncology and neurology. Their scientific rigor and commitment to advancing therapeutic accuracy create a stimulating environment for professionals keen on impactful biotechnological innovation. This setting not only champions industry leadership in medical diagnostics but also fosters a culture prioritizing breakthrough research and patient welfare.
Company Stage
IPO
Total Funding
$559.6M
Headquarters
Billerica, Massachusetts
Founded
2007
Growth & Insights
Headcount
6 month growth
↑ 8%1 year growth
↑ 20%2 year growth
↓ -8%INACTIVE