Takeda

Lead training team members in meeting goals in absence of Training Supervisor.. This position is a B - Shift role that operates on a 2-2-3 rotating shift scheduled from 5:00 AM - 5:30 How you will contribute Collaborate with shift Supervisors to develop and implement learning plans.. (Preference) In-depth manufacturing process knowledge, including proficient knowledge and qualification in one or more processes, intermediate suspension, centrifuge operation, chromatography, COP, CIP, filtration, UF/DF, filter press operation and facility/equipment cleaning.. Working knowledge of applicable SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs. Familiarity with cGMP audit process, exception management, quality systems, and interpretation of regulations.. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet, and bodyNo make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

operator

Description About the role Responsible for scheduling, conducting, and documenting Structured-On-The-Training (SOJT) and Instructor Led Training (ILT) from basic to complex learning activities. Participate in employee performance improvement initiatives and collaborate with Operations to increase effectiveness of job specific GMP training. Collaborate with Subject Matter Experts (SME's) within multiple process areas, to process project working and continuous improvement teams. Lead training team members in meeting goals in absence of Training Supervisor. This position is a B - Shift role that operates on a 2-2-3 rotating shift scheduled from 5:00 AM - 5:30 How you will contribute Collaborate with shift Supervisors to develop and implement learning plans.Schedule, and provide hands on training on core manufacturing tasks, SOP's, and equipment operation per training plan.Conduct periodic operation audit sessions for employees evaluating compliance (including investigations) effectiveness of training, and comprehension of training.Support development of cross-training plans for assigned areas to support their goals and objectives.Deliver New Employee Orientation training session.Evaluate, review, and revise/or create SOPs following periodic requirement.Maintain training matrices and training plans to identify training gaps, track status and workforce levels.Assign training roles with current Learning Management System (LMS) to employees based on current need and ensure personnel training requirements are met.Create training materials that supplement associated SOPs and process for assigned areas.Demonstrate mastery of applicable process concepts, technical content, course curriculum and training methodologies.Lead and mentor the L&D team members.Collaborate with management, cross-site personnel, and internal/external resources to develop and implement new training and improve the training program.Participate in regulatory inspections/audits. What you bring to Takeda Requires minimum high school diploma or GED. 6+ years of experience or AA or higher with 4+ years related work experience.(Preference) In-depth manufacturing process knowledge, including proficient knowledge and qualification in one or more processes, intermediate suspension, centrifuge operation, chromatography, COP, CIP, filtration, UF/DF, filter press operation and facility/equipment cleaning.Solid knowledge in Good Manufacturing Practices and Good Data & Documentation Practices (GDDP).Experience training people in a regulated working environment. This may include the technical aspects surrounding theory and application.Proficient in Microsoft applications such as Word and Excel.Working knowledge of applicable SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs. Familiarity with cGMP audit process, exception management, quality systems, and interpretation of regulations.Able to solve technical, compliance, or operational problems as assigned.Experience of project management.Expertise in applying LEAN or Six Sigma principles and continuous improvement methodologies is a plus.Must be proficient in written and oral English. Important Considerations Must be able to lift, push, pull and carry up to 50lbs.In general, your work will be a combination of sedentary work and walking around observing conditions in the facility.Will work in controlled environments requiring special gowning.Will follow gowning requirements and wear protective clothing over the head, face, hands, feet, and bodyNo make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.Will work in a cold and wet environment.Must be able to work multiple shifts, including weekends.Can work overtime.May work in a confined area.Some Clean Room and cool/hot storage conditions. More about us 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. This posting excludes Colorado applicants. #GMSGQ #LI-LA1Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.For Location:USA - IL - Round Lake - Drug DeliveryU.S. Hourly Wage Range:$26.92 - $42.31The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.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 StatementLocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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