Quality Analyst II
Location: Thousand Oaks
Posted on: September 15, 2023
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAbout the role:You will perform the daily
quality operations. You will identify and assess quality risks in
activities and processes according to regulatory agency rules,
guidelines, and Takeda quality practices.How you will
- Review important documents, against Standard Operating
Procedures (SOPs) for accuracy and compliance based on regulatory
requirements and internal guidelines.
- Identify areas of nonconformance and escalate to management
(Manufacturing and Quality) for initiation of a Deviation.
- Conduct, perform investigations for non-conformances within
respective area. Help identify corrective actions to prevent
- Administer and maintain relevant databases, prepare, and issue
reports defined by the area, and develop custom reports.
- Support process with closure of observations/audit items.
- CAPA Investigations for issues within respective area.
- Prepare metrics for the Management Review of Quality
- Audit/review documents for completeness, CGMP's, company
procedures and verification of data. Correct any deficiencies
- Assist and prepare Annual Product Review (APR) for
- Write Technical reports (e.g., PQR and YBPR).
- Help with the development, and revision of SOPs to support
Division Procedure Compliance and continuous improvement
- Knowledge of FDA regulations, Application of Good Laboratory
Practices and Application of Good Manufacturing Practices.What you
bring to Takeda:
- High school diploma or equivalent required.
- Bachelor's degree in a scientific discipline.
- 3+ years of related work experience.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
- 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 opportunities
- Tuition reimbursementImportant 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:
- The physical exertion of this position is sedentary.
- Batch record Review on the Floor (BRR) may require being on
your feet for long periods of time.
- Normal office environment.
- May manage hazardous wastes in compliance with company
procedures & State/Federal/Local hazardous waste regulations.
Responsibilities may include identifying, handling, generating,
accumulating, storing, labeling, and on-site transporting of
- May 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
- Will need to remove all make-up, jewelry, contact lenses, nail
polish and artificial fingernails while in the manufacturing
- May work in a cold, hot or wet environment.
- May work around chemicals such as alcohol, acids, buffers and
Celite that may require respiratory protection.
- May require immunization before performing work within the
- May require overtime, weekend, and holiday work.
- May be assigned to a different shift.More about us:At Takeda,
we are transforming patient care through the development of novel
specialty pharmaceuticals and the best patient support programs.
Takeda is a patient-focused company to 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.Base Salary Range: $53,000.00 -
$76,000.00. Employees may also be eligible for Short-term and
Long-Term Incentive benefits. Employees are eligible to participate
in Medical, Dental, Vision, Life Insurance, 401(k), Charitable
Contribution Match, Holidays, Personal Days and Vacation, Tuition
Reimbursement Program and Paid Volunteer Time Off.The final salary
offered for this position may take into account many factors
including location, skills, education, and experienceThis posting
excludes Colorado applicants.#GMSGQ#ZR1#LI-MA1EEO 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 - Thousand Oaks - Rancho ConejoWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda, Thousand Oaks , Quality Analyst II, Professions , Thousand Oaks, California
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