Quality Control Analyst II

Job Description 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, SoftmaxPro, Charles River Endoscan, MODA, and Empower). This shift will be working from Monday to Friday, 2pm-10:30pm. Responsibilities Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal). Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability. 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. Complete all testing, including special project and protocol testing in a timely and appropriate manner. Maintain data integrity and ensure compliance with company SOPs, 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. Decisions have moderate impact on future QC processes and procedures that impact batch disposition. 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. Perform other duties as assigned. Qualifications 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. General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service. 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. Must display eagerness to learn and continuously improve. Important Considerations 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. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. Stand or sit – Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment. Carry weight, lifting – Frequently moves laboratory materials and portable instruments weighing up to 30 pounds. Climb – Occasionally ascends/descends step ladders to reach materials and/or stairs to collect samples. Dexterity/balance – required to gown for cleanroom work, balance and dexterity are required. 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. Willingness to travel to various meetings or training, this could include overnight trips. Requires 0‑5% travel. Compensation and Benefits Summary Brooklyn Park, MN U.S. Hourly Wage Range: $24.76 - $38.87 U.S. based employees may be eligible for short‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. #J-18808-Ljbffr