OverviewThis is a great opportunity to join a dynamic group within a growing company as a Sr. QA Laboratory Engineer. This is a lab-centered role, with a focus on production. This position is at the Waters Milford, MA facility.
In this role, the Sr. QA Laboratory Engineer, will investigate and analyze molecular contamination for adherence to Waters Critical Clean Specification, and evaluate HPS products in the Quality Assurance Laboratory. This individual will drive quality improvements in equipment and processes from investigations and experiments, thereby directly benefitting end users with product-release activities. The Sr. QA Laboratory Engineer designs, validates, and executes analytical test methods (ex. mass spectrometry, liquid chromatography, UV, and fluorescence detection), analyzes results, interprets data, and reports conclusions. The Sr. QA Laboratory Engineer additionally supports the Quality Management System. This is a dynamic position, where the individual will interact with multiple functions (R&D, Machining Center, Design Engineering, Test Engineering, Reliability Engineering) and multiple domestic & international manufacturing sites to resolve quality issues.
Partner with cross-functional teams to streamline processes, improve product quality, and ensure the timely resolution of NCRs, CAPAs, and quality investigations.
Drive continuous quality improvement initiatives across antibody- and chemical-based product lines through effective management and timely closure of NCRs, CAPAs, deviations, and investigations.
Support Manufacturing, Production, R&D in the anti-body and chemical based product lines.
Responsibilities- Execute day-to-day product acceptance and release testing within the Quality Assurance Laboratory using mass spectrometry, liquid chromatography, UV, fluorescence, and other instrumentation.
- Validate test methods for cleaning and HPS processes as well as for product release.
- Support the Quality Management System by generating, modifying, reviewing, and approving quality records (standard operating procedures, protocols, reports).
- Monitor and maintain the laboratory environment (ex. reagents, calibrations, preventive maintenance, and safety practices) while adhering to good documentation practices (GDP).
- Collaborate, troubleshoot (driving to root cause), and drive improvement in procedures/processes.
- Timely closure of NCRs, CAPAs, and investigations
QualificationsEducation:
- Bachelors Degree in Science (ex. Chemistry, Biochemistry, Molecular Biology), Engineering (ex. Chemical, Materials, Environmental), or technical field with emphasis on laboratory and analytical skills.
- Masters Degree in any of the noted fields is preferred.
Experience:
- Minimum 5 years industry experience (diagnostic devices, pharma, biotech).
- Minimum 3 years of laboratory experience
- Practiced experience with mass spectrometry, liquid chromatography, TUV, plate reader, or similar analytical technique(s).
- Professional focus within lab release testing, manufacturing, or production roles.
- Exposure to process and/or software validation methods.
- Excellent communication and interpersonal skills.
- Ability to work independently across multiple departments.
- Excellent report writing and attention to detail.
Desired Qualifications:
- Laboratory experience within a Quality Assurance/Control Laboratory
- Experience using Waters liquid chromatographs and mass spectrometers (UNIFI/Empower/MassLynx softwares)
- Working knowledge of quality management systems (ISO 13485, 21 CFR Part 820).
- Knowledge/Experience with a LIMS (Laboratory Information Management System)
- Strong understanding of quality system principles and continuous improvement methodologies.
- Experience with quality management systems and electronic quality record systems.
- Ability to interpret technical drawings, specifications, and manufacturing documentation.
- The ideal candidate will possess a strong interest in chemistry, biotechnology, and diagnostic products, with an eagerness to understand the manufacturing and quality requirements of antibody-based and chemical assay products.
