- Execution of testing for incoming raw materials, intermediate bulks, finished goods, and stability samples following SOPs, Work Instructions (WIs), and GMP guidelines
- Document and analyze data following approved work instructions while adhering to GMP guidelines.
- Assist with the maintenance of QA monitoring programs, such as internal audits.
- Support new process development and continuous improvement by integrating QC tools and techniques.
- Participate in lab investigations as required.
- Maintain QC inventory and tracking systems.
- Update and monitor data trending of reagents and QC tests.
- BS in the Life Sciences such as Biochemistry, Molecular Biology, Biotechnology, etc., with 1-3 years in an industry setting. In vitro diagnostics environment is preferred.
- Understanding of molecular biology, assay development, and DNA diagnostic chemistry is highly desirable.
- Experience in laboratory techniques such as qPCR, UV/VIS, and buffer formulation are required.
- Understanding and awareness of cleanliness in a PCR laboratory to avoid contamination is required.
- Strong analytical and problem solving skills.
- High attention to detail adhering to regulatory guidelines.
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Quality Control Associate - Lexington, United States - T2 Biosystems
Description
Job Description
Job DescriptionDescriptionWe are seeking a bright, energetic and detail-oriented individual to join our team as a Quality Control Associate. This is an exciting role that will serve as the primary quality partner for our reagent manufacturing operations and is responsible for promoting product quality and quality system compliance across those areas.The ideal candidate will be someone that enjoys working as part of a fast paced, cross-functional team, balancing multiple tasks and focused on achieving results. In addition, we're looking for someone that thrives in a rapidly growing environment and is interested in developing and advancing their career along with the organization.
Responsibilities
Skills and Expertise
