QC Analyst I, Analytical

WHO WE ARERoslinCT is a world-leading cell therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.THE ROSLINCT WAYHere at RoslinCT, our team can contribute to the development and delivery of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.ACCELERATING YOUR FUTUREThe Quality Control Raw Material Analyst will be responsible for QC inspection and sampling of incoming raw materials, author and revise material specifications, perform routine and non-routine QC testing on raw materials, in-process samples and finished products in support of cGMP manufacturing including pH, Osmolality, appearance, visual inspection, cell counting and related methods. This position will also provide support to assist the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing.The QC Analyst I, Analytical will partner with the analytical team, interface with multiple groups, and must have the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot.He/she will be responsible for authoring Standard Operating Procedures (SOPs), specifications and Test Methods. He/she will assist in the implementation of new assay methodologies and the associated instrumentation.Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs.HOW YOU WILL MAKE AN IMPACTPerform QC Inspection and sampling (as needed) on all incoming raw materials and packaging components following detailed written proceduresAuthor material specification documents or SOP’s or other procedures (as needed) to support the site Raw Material ProgramPerform material inspections via an electronic systemAssist in preparing and sampling raw materials for shipment to external testing laboratoriesPossess the ability to evaluate certificate of analysis of chemicals/raw materials/packaging componentsPerform routine and non-routine QC testing on raw materials, in-process samples and finished products in support of cGMP manufacturing of cell therapy products, as neededOperate and maintain laboratory equipment and instruments, ensuring proper calibration and adherence to cGMP ComplianceSupport analytical equipment installation and qualification, ensuring 21 CFR Part 11 complianceWork collaboratively with cross functional departments, as neededAdhere to compliance of Warehouse area in terms of Isolation of Quarantine and Released materialsApply technical knowledge and abilities to ensure all testing is performed in a compliant mannerParticipate in internal and external audits, inspections, investigations, change controls and CAPAs, as neededWork independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projectsCommunicate effectively with cross-functional peers, and department management regarding task completion, roadblocks, and needsOther duties as assigned by managementWHAT YOU WILL BRINGBachelor's Degree in scientific discipline0-2+ years of relevant raw material experience in cGMP QC Laboratory, or equivalent (raw material testing is a plus)Knowledge in ANSI.ASQ Zl.4 sampling plans (desired)Hands-on experience with various analytical techniques such as pH, osmolality, identifications, ELISAs, cell-based assays (desired)Knowledge of cGMP/ICH/FDA regulationsAbility to independently prioritize/manage activitiesAbility to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detailProficient in MS Office applications and information technologies that support documentation and data management systems. Experience in LIMS.Strong troubleshooting, problem-solving skills, oral and written skillsExperience working in a team environment and communicating effectivelyWORKING CONDITIONSMonday-Friday, 1st Shift (e.g., 8am-5pm)Flexible work schedule – Some nights, weekends and holidays will be required on occasion in support of 24/7 manufacturing operations.Job will require ability to lift up to 25 pounds, stand for extended periods of time, and complete repetitive tasks.Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.OUR COMMITMENTAll RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.