Company: Takeda Pharmaceutical
Location: Thousand Oaks
Posted on: May 15, 2022
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Job Title: Compliance Investigator
Location: Thousand Oaks, CA
About the role:
The Compliance Investigator conducts root cause investigations,
closes deviations, supports assignment of proper corrective
actions, and facilitates implementation for Manufacturing under the
direction of Compliance Management.
How you will contribute: 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.
Ensure that the daily operations of assigned functional area are
met through scheduling, troubleshooting, and coaching.
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.
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
May be required to conduct investigations and/or audits into
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
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,
reporting shift activities, and leading daily operations to ensure
coordination and efficiency.
Write and manage deviations (CAPA investigations, UIs, ICARs, OOXs,
containment and/or corrective actions) under the direction of
Lead and/or facilitate problem solving events. Lead the
investigation closure of manufacturing compliance related
documents. Use quality and statistical tools to identify and
implement proper corrective and preventative actions to
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
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
Participate in regulatory and non-regulatory audits.
May perform other duties as assigned.
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
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,
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
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
Ability to analyze and interpret scientific and statistical
Experienced understanding of cGMP and other regulatory guidelines
applicable to the medical/bio-tech industry.
Lead investigation and provide comprehensive investigation write up
Working knowledge of Quality Systems.
Good computer skills and working experience with Microsoft Office
What you bring to Takeda:
--- Bachelor's degree preferred with 2-4 years of manufacturing
What Takeda can offer you: Comprehensive Healthcare: Medical,
Dental, and Vision
Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs and company match of charitable
Family Planning Support
Professional training and development opportunities
At Takeda, our patients rely on us to deliver quality products. As
a result, we must follow strict rules in our manufacturing
facilities to ensure we are not endangering the quality of the
product. In this role, you may:
The overall physical exertion of this position is sedentary
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
Work in a cold, wet environment.
Work around chemicals such as alcohol, acids, buffers and Celite
that may require respiratory protection.
Although assignments will be made specific to working hours,
flexibility is expected, with the understanding that process
validation and production objectives may necessitate changes in
work hours, duties, and responsibilities.
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
This posting excludes Colorado applicants.
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.
USA - CA - Thousand Oaks - Rancho Conejo
Keywords: Takeda Pharmaceutical, Thousand Oaks , Compliance Investigator, Other , Thousand Oaks, California
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