Quality Control Analyst II

Quality Control Analyst II

As a Quality Control Analyst II, you will execute and review routine in-process, drug substance, and stability test methods in a timely manner. You will use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, Charles River Endoscan, and MODA). This shift will be working from Saturday to Tuesday.

Your responsibilities will include maintaining lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal), conducting test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. You will own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls), demonstrate a functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures (SOP's), work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions as required. You will complete all testing, including special project and protocol testing in a timely and appropriate manner, maintain data integrity and ensure compliance with company SOP's, specifications, and cGMP regulations, independently exercise judgment within generally defined Quality Control (QC) procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions, initiate and own laboratory investigations, basic complexity low and medium risk deviations, CAPA's, and change controls of moderate scope within the electronic Quality Management System, participate in cross-functional teams, draft studies and investigations of moderate scope and work on problems where the situation or data requires a review of identifiable factors, author new SOP's and initiate changes to existing procedures, train new QC Analysts on routine procedures and practices, may be required to work overtime or be assigned to a different shift as needed, perform equipment maintenance and calibrations as required, complete mandatory training within required timeframe, and perform other duties as assigned.

You will need a Bachelor's or master's degree in any Life Sciences with relevant laboratory coursework, 3-6 years of relevant experience preferred, previous experience in a regulated environment preferred, must understand laboratory instrumentation, must be able to communicate effectively with managers and peers, must be able to read, write, and converse in English, must have basic computer skills, good interpersonal skills and able to work effectively and efficiently in a team environment, knowledge of cGMP manufacturing, knowledge of chemical, biological and/or microbiological safety procedures, and must display eagerness to learn and continuously improve.

In this role, you may work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. You may need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. You may work in a cold, wet environment. You may work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. You may work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. You must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment. You frequently moves laboratory materials and portable instruments weighing up to 30 pounds. Occasionally ascends/descends step ladders to reach materials and/or stairs to collect samples. Required to gown for cleanroom work, balance and dexterity are required. You may be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department. You may be willing to travel to various meetings or training, this could include overnight trips. Requires 0-5% travel.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.