SENIOR QUALITY ANALYST

Job Description This position reports to Shift (3) Nights, which includes a shift differential according to the shift schedule.
This shift schedule is Monday-Friday from 10 PM to 6.
AM.
Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
The company reserves the right to adjust your shift schedule, or location if necessary.
About the role.
You will perform all primary Quality Assurance activities for Teardown, Fractionation, and Purification observing cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating procedures.
You will provide daily Quality on the Shop Floor oversight to manufacturing batch record and documentation review for accuracy and compliance to procedure, Quality on the Shop Floor walkthroughs to assure cGMP compliance and resolution of issues, participating in troubleshooting and problem solving of manufacturing issues and supporting daily Return to Operation assessment and Change Control (insignificant changes) process.
You will provide Quality Assurance support to Site Critical Systems, Facilities and Engineering processes.
You will assure compliance with cGMP, GDDP, and company procedures internal and external audits.
Identify potential Quality and compliance risk in activities and processes according to procedural requirements, Takeda Quality Standards.
Provide assessments to support good understanding of current regulatory requirements i.
., FDA, ISO, and Takeda Quality Systems, and serve as a plant resource for compliance to these requirements.
Uphold Takeda's Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and overseeing and demonstrating commitment to Quality.
How you will contribute.
Partner up with Manufacturing for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures.
Perform scheduled and unscheduled walkthroughs of Manufacturing, facilities, and supporting areas for verification of acceptable cGMP Facilities and equipment conditions.
Obtain resolution on issues identified as non-conformance.
Interpret and evaluate issues for acceptability to standards, procedures and regulatory requirements.
Help document issues with immediate corrections and corrective actions.
Work with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, create cost savings, and provide new product support.
What you bring to Takeda.
High school diploma or GED.
6+ years of experience or AA or higher with 4+ years related work experience Knowledge of Regulations, Application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).
General knowledge of biopharmaceutical / biotech manufacturing industry and systems.
Good investigational experience.
See the actual process on the floor (GEMBA) where issue occurred and recommend immediate corrections and corrective actions for determined root cause.
Have good critical thinking and problem-solving skills (DMAIC and Lean).
Perform and analyze trending using DeltaV system and EBM.
Support department / plant goals.
Approve investigations as assigned Yellow Belt/ Green Belt training or certification.
Important Considerations 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.
You may.
Must be able to lift, pull, and carry up to 25 lbs.
In general, you will have a combination of sedentary work and walking around observing conditions in the cGMP facility.
May wear personal protective equipment (PPE) and other clean room garments daily.
This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
Need to remove all make-up, jewelry, contact lenses, nail polish and 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,.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
#GMSGQ #ZR1 #LI-MA1 Takeda Compensation and Benefits Summary We 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 - CA - Los Angeles U.
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Hourly Wage Range.
$ The 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.
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based e mployee s may be eligible for s hort - t erm incentives.
U.
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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.
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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.