Sr. QA Laboratory Engineer
On-siteMilford, Massachusetts, United States
Milford, Massachusetts, United StatesOn-siteFull TimeSenior LevelBachelors DegreeLarge
Full TimeSenior LevelBachelors DegreeLarge
Job Summary
Execute day-to-day product acceptance and release testing using mass spectrometry, liquid chromatography, UV, and fluorescence instrumentation. Validate test methods for cleaning and HPS processes while generating, modifying, and approving quality records within the Quality Management System. Monitor laboratory environments for reagents, calibrations, and safety practices, then collaborate with cross-functional teams to drive root cause analysis and timely closure of NCRs, CAPAs, and investigations across antibody and chemical product lines.
Required Qualifications
- Bachelors Degree in Science (ex. Chemistry, Biochemistry, Molecular Biology), Engineering (ex. Chemical, Materials, Environmental), or technical field with emphasis on laboratory and analytical skills
- 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
- Masters Degree in any of the noted fields is preferred
- 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
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