A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
Quality Control Analyst II - Molecular Biology Tandym Group - 3.8 Woburn, MA Job Details Full-time | Contract Up to $48 an hour 23 hours ago Qualifications Biology Stability testing Experimental data reports Biochemistry Quality records maintenance Master's degree in chemistry Laboratory equipment performance testing and validation Stability studies in drug product development Pharmaceutical laboratory environment PCR machines Laboratory instrument validation Master's degree in Biochemistry Production deviation management Performance Reporting Corrective and preventive actions (CAPA) GMP Mid-level Master's degree in biology Technical report writing Molecular diagnostic equipment Bachelor's degree in biology Master's degree Quality reports Quality control data reporting Laboratory reports Biochemical laboratory techniques Laboratory quality control records management Research report preparation Bachelor's degree Quality assurance standard operating procedures Full Job Description A pharma company in Massachusetts is looking to add a new Quality Control Analyst II to join their Molecular Biology team.
Responsibilities:
Perform routine QC testing including but not limited to: ddPCR, dPCR, and qPCR test methods in support of in-process, release, and stability Review and approval of cGMP analytical data for release and stability testing from internal and external analytical test methods Support the QC Molecular Biology laboratory operations (ex. Instrument qualification and maintenance, housekeeping, qualify critical reagents, etc.) Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs Author analytical method performance trend reports, as needed Work with cross-functional teams with both internal and external stakeholders Perform other duties, as needed
Qualifications:
2+ years of related industry experience Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry Bachelor's and/or Master's Degree n Biochemistry, Biology, Chemistry or a related discipline Hands-on experience with performing dPCR, ddPCR and/or qPCR test method execution Strong collaboration and team-working skills Strong communication, interpersonal and organizational skills Ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
