QC Lab Tech/Chemist

Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. At MilliporeSigma in Burlington, MA, we are seeking a detailed and results-oriented Chemist for our Extractables and Leachables (E&L) team within the North American Validation Services group. The successful candidate will be a part of a diverse team of scientists, specialists, and assistants, ensuring the delivery of compliant testing services that align with business objectives. In this role you will autonomously perform feasibility, standard and non-standard Extractables and Leachables testing following Protocols and SOPs on HPLC, GCMS and LCMS equipment.

Perform all laboratory activities strictly in accordance with approved SOPs, analytical methods, study protocols, laboratory instructions, and applicable safety requirements

Prepare samples for GC- and LC-based analysis, including but not limited to liquid-liquid-extraction, dilution, filtration, concentration, derivatization, and transfer into analytical vials, as specified in the approved method or protocol

Operate GC and LC instrumentation in accordance with approved SOPs, analytical methods, study protocols, instrument procedures, and training requirements

Prepare test solutions, calibration standards, system suitability solutions, blanks, spiked samples, and quality control samples according to approved procedures

Thoroughly read protocols and plan proactively for testing including equipment and chemical needs

Generate valid test data (ensuring accuracy and completeness) for customers in a timely manner according to Good Documentation Practices and ALCOA+ principles

Handle solvents and customer product samples in accordance with all safety rules (PPE, MSDS and EHS recommendations to be considered before handling the products)

Assist with self-inspections and audits and work as "Junior SME" to support lab on technical guidelines

Maintain a Growth Mindset, seeking opportunities to improve test efficiency and processes, approaching change with a spirit of curiosity

Bachelor's Degree in Chemistry, Biochemistry or other Science discipline

• 1+ years of experience in analytical chemistry within the pharmaceutical or medical device industry
• 1+ years of experience with headspace GC, GC-MS, LC-MS, HPLC, UHPLC, or high-resolution mass spectrometry

Experience in extractables and leachables testing or related trace-level analytical testing

Experience with laboratory electronic systems, including but not limited to: Mango, Trackwise, SFDC, Sharepoint, LabVantage and Oracle

Excellent knowledge of good laboratory practices, cGMP, regulatory guidance, and recommendations as well as demonstrable operational management abilities

Strong background in Chemistry, excellent organizational and interpersonal skills, and a commitment to safety and compliance

Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!