Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Operations Analyst in our Thousand Oaks, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliverBetter Health and a Brighter Futureto people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

The position will conduct root cause investigations, close deviations, support assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.

Perform calculation, data collection in support of site, global CI initiatives, and management reviews. Participate in the development and technical writing of documentation for the validation of equipment and required to support testing of the Thousand Oaks Manufacturing Facility. Lead and/or drive completion of Lean or Six Sigma improvement projects and responsible milestones, as assigned.  May function as a backup Supervisor. Ensure that the daily operations of assigned functional area are met through scheduling, troubleshooting, and coaching.

Essential Duties and Responsibilities

Support and/or lead continuous improvement projects such as Yellow Belt, Green Belt, 5S, Kaizen, Just-do-it’s, VIPs using Lean/DMAIC concepts and philosophy.
Assist Compliance Supervisor in leading daily operations to ensure coordination and efficiency.
Participate in the generation of test plans, protocols, and reporting documentation for the validation of equipment supporting testing of the Thousand Oaks Facility.
Perform review of test data with application of GDP.
Use Global LIMS or other computerized systems for trending test results.
May be required to conduct investigations and/or audits into Alert/OOL excursions.
Actively contribute to a team setting at the Thousand Oaks Manufacturing Facility and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed.
Provide training and work direction for assigned functional areas. 
Investigate deviations and write exception documents as required, using problem-solving tools as needed.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
May be required to generate, execute, and/or summarize studies and/or review/revise of SOPs.
Complete and/or direct completion of special project/protocol testing in a timely manner.
Assist Compliance Supervisor in updating department metrics and report shift activities, as assigned.
Ensure personal training requirements are met and that training records are current.
May perform disposal of hazardous waste.
Write and manage deviations (CAPA investigations, UIs, ICARs, OOXs, containment and/or corrective actions) under the direction of Compliance Management.

Lead and/or facilitate problem solving events. Lead the investigation closure of manufacturing compliance related documents. Using quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance.
Represent the departments during the product release process, compliance, and Continuous Improvement projects and audits.
Participate in deviation related meetings and provide feedback, leadership, and support to manufacturing supervisors, trainers and manufacturing technicians on the status of compliance of the department.
Conduct mediations to ensure timely release of product for customers. Assist in meeting product release time goals.
Emphasize training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.
Identify and implement process improvement and Value Improvement Projects (VIP) to drive success in the areas of compliance, throughput, workplace safety, cost effectiveness, and product lead time.
Participate in regulatory and non-regulatory audits.
Other duties as assigned.

Qualifications

Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
Effective organizational skills and ability to plan and suggest resolutions to technical problems.
Demonstrated working knowledge of assays/equipment in functional area.
Must be detail-oriented, conscientious, and responsible.
Capable of applying some decisions-making to problem-solve technical, compliance, or operational problems, as assigned.
Effective interpersonal communication.  Must have effective verbal and written communication skills.
Can demonstrate the ability to guide people, encourage teamwork, and teach.
Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs.
Good project management skills a plus.
Must be able to learn new computer systems and programs in a timely manner.
Demonstrate interpersonal skills with the ability to interface and influence with personnel of all levels and participate effectively and efficiently in a team environment.
In-depth process knowledge of related manufacturing equipment and processes.
Ability to analyze and interpret scientific and statistical data.
Experienced understanding of cGMP and other regulatory guidelines applicable to the medical/bio-tech industry.
Lead investigation and provide comprehensive investigation write up and/or presentations
Working knowledge of Quality Systems
Good computer skills and working experience with Microsoft Office applications.

Education and/or experience

Bachelor’s degree preferred with 2-4 years of manufacturing experience. 

Physical Demand

The overall physical exertion of this position is sedentary work.  Must be able to perform gowning operations, including donning over garment and head cover.
May be required to balance occasionally, when gowning for clean rooms.
May be required to stand occasionally, when inside clean rooms.

Working Environment

Position requires frequent usage of a personal computer. 
On occasion, the incumbent will be required to enter the production area and may therefore be exposed to hot, cold, and/or wet environments.
NOTE: Although assignments will be made specific to working hours, incumbent is expected to be flexible in this regard, with the understanding that process validation and production objectives may necessitate changes in work hours, duties and responsibilities.
May need to work in controlled or clean room environments requiring special gowning.  Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.  No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in this work
May be required to work or be assigned to a different shift as needed.
Must be able to work more than 8 hours a day or 40 hours a workweek as required.
Overtime may be required at times.
Will have interaction with other people (cross-functional).
Pace may be fast and job completion demands may be high.

WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs