*Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers.
See below or here for more info.
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .
I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Monday to Friday 1:30 pm to 10:30 pm
Summary:
Responsible for quality oversight of validation activities at the Takeda Los Angeles facility.
This person will have quality signatory responsibility for approval of qualification, validation, and final report documents.
Ensure that the validation and compliance requirements are met according to guidelines and Takeda standard operating procedures.
Play an active role during the planning process of validation activities.
Function as the leading role in formulating validation strategy.
Proficient in facility quality systems and participates as subject matter expert of validation requirements.
Review qualification / validation activities (Facility, Equipment, Critical systems, Automation systems, Process and Cleaning, etc.).
Essential Duties and Responsibilities:
Responsible for reviewing pertinent documents, against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
which comprises the majority of the work performed.
Provide validation expertise and support for the development (or modification phases) of manufacturing facility, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
Review from a quality perspective, the validation approach and documentation as required to assure compliance with procedures and regulatory submissions Assure the monitoring and reporting program to maintain the accurate validation state of process/systems by reviewing and approving the facility validation master plan.
Review from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.
Participate in the risk assessment related to the project.
Assure requirements traceability throughout the whole project life cycle.
Provide support in all quality-related issues, including GMP regulations, Evaluate, analyze, and approve deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up upon pertaining to validation protocols.
Take part in internal/external audits.
Provide the required information to support the preparation of facility & process related files for the various regulatory agencies.
Attend cross-functional planning meetings to ensure consistent validation approach.
Coach and mentor employees in order to improve team performance and individual development.
May perform other duties as assigned.
Qualifications:
Strong interpersonal skills and great attention to detail are necessary.
Must be a strong team player with good problem solving, and good verbal and written communication skills.
Must be able to handle multiple projects concurrently, have computer experience and have extensive knowledge of FDA Regulations and GxPs.
Must have experience in pharmaceutical/biotech validation which includes the writing and executing of protocols.
Must have experience or advanced training and demonstrate proficiency (e.g.
Takeda’s quality systems such as validation, change control, etc., statistical methods/six sigma training, problem analysis and resolution, design of experiments and process development/pilot scale work).
Proficient in relevant products or process development processes, as applicable.
The individual will have proficiency in purification processes for plasma/biotech manufacturing operations.
Successful track record of analyzing complex technical problems.
Demonstrates good troubleshooting and decision-making abilities.
Recognized as a technical expert by peers.
Must be self-motivating and able to handle multiple projects concurrently.
Ability to design and influence in own area of expertise.
Extensive cross-functional team experience, including technical and non-technical work.
Ability to organize and present technical and project management overviews, without assistance, to upper-management.
Must have the following personal attributes:integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Must have passion to innovate and drive for solutions.
Must display personal accountability for results and integrity.
Must display eagerness to learn and continuously improve.
Must have uncompromising dedication to quality.
Must have relentless focus on rapid and disciplined action.
Must have respect for individuals and the diverse contributions of all.
Education and/or experience:
Typically requires BA or BS degree preferably in the engineering or science field.
Minimum 7 years of relevant experience for non mgr role; 5+ years’ experience with 2+ years on leadership role.
Physical Demands:
• Must be able to lift, push, pull and carry up to 25 lbs.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to work in controlled 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 the manufacturing environment.
Will work in a cold and/or wet environment.
Must be able to work multiple shifts, including weekends.
Non-Exempt Roles only: Must be able to work overtime as required.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
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.
Sign up to receive the latest career opportunities directly to your inbox.
First Name
Last Name
Phone Number
Email Address
Select a job category from the list of options.
Select a location from the list of options.
Finally, click “Add” to create your job alert.
Job Category
Location
Quality, Los Angeles, California, United States Remove
Upload Resume
By submitting your information, you acknowledge that you have read our applicant privacy notice and consent to receive email communication from Takeda Pharmaceuticals.
Job Seekers: Protect yourself against identity theft
Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information.
They visit job-related websites and invite candidates to online chats.
During the chat, they press job seekers to provide bank account information and Social Security numbers.
At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews.
And we are investigating ways to mitigate or stop this scheme.
If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: https://www.consumer.ftc.gov/articles/0497-credit-freeze-faqs; 2) file a complaint with the U.S.
Federal Trade Commission: https://www.ftccomplaintassistant.gov/; and/or 3) file a report with your local police department.
Copyright 1995-2021 Takeda Pharmaceutical Company Limited.
All rights reserved.