Senior Quality Analyst
Company: Takeda Pharmaceutical
Location: Los Angeles
Posted on: September 17, 2024
Job Description:
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 DescriptionThis 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 6:30 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.e., 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
ConsiderationsAt 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-MA1Takeda Compensation and Benefits SummaryWe
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 AngelesU.S. Hourly Wage
Range:$26.92 - $42.31The 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.S. based employees may be eligible for
short-term incentives. U.S. 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.S. 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 StatementTakeda 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.LocationsUSA - CA - Los AngelesWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Huntington Park , Senior Quality Analyst, Professions , Los Angeles, California
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