SENIOR QUALITY ANALYST

Job Description This position will report to either Shift 2 (Swing) or Shift 3 (Nights).
Please see detailed information below.
Shift 2 (Swing).
This shift schedule is Monday-Friday from 2.
PM to PM.
Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
Shift 3 (Nights).
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.
As a Senior Quality Analyst, you will perform all primary Quality Assurance activities for Teardown/ Fractionation (B5) or Purification (B8).
This includes providing daily Quality on the Shop Floor oversight.
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 trouble shooting and problem solving of manufacturing issues and supporting daily change control processes (insignificant changes and return to operations) following FDA and Regulatory standards, ISO requirements and internal standard operating procedures.
Responsibilities Partner up with Manufacturing for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures.
Review and release batch records and associated documents against Standard Operating procedures and internal guidelines as assigned.
Perform scheduled and unscheduled walkthroughs of Manufacturing, facilities and supporting areas for verification of acceptable cGMP Facility and equipment conditions and resolution of actions.
Interpret and evaluate issues for acceptability to standards, procedures and regulatory requirements.
Obtain resolution on issues identified as non–conformance.
Provide guidance on documentation of issues with immediate corrections and corrective actions.
Work with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, generate cost savings, and provide new product support.
Perform initial investigations and reviews Deviations, CAPAs, and User Interventions.
Qualifications Typically requires Bachelor's Degree in Science-Chemistry or Biological Science.
4+ years of 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 theories and processes.
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).
Be able to perform and analyze trending using DeltaV system and EBM.
Yellow Belt/ Green Belt training/certification.
Important Considerations Must be able to lift, push, pull and carry up to 25 lbs.
In general, you will have 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 body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
Will work in a cold, wet environment May work in a confined area.
Some clean room and cool/hot storage conditions.
May be required to work off-shifts, including weekends, as assigned.
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.