Quality Control Analyst - Microbiology
Location: Thousand Oaks
Posted on: May 25, 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 DescriptionLocation: Thousand Oaks, CAAbout the
role:As the Quality Control Analyst in the QC Microbiology Lab, you
will conduct biological or chemical and physical analyses on raw
materials, in-process samples, final product samples and other
samples collected from manufacturing areas.How you will
- Use laboratory instrumentation including analytical equipment,
autoclaves, and incubators.
- Perform assays requiring precise analytical skills and
understanding of biology and chemistry principles.
- Conduct biological, chemical, and physical analyses on raw
materials, initial, in-process and final products, and samples
collected from environmental monitoring.
- Maintain data integrity and ensure compliance with company SOPs
and specifications, FDA, GLP, QSR and CGMP regulations.
- Investigate nonconformance's and write exception
- Complete multiple tasks concurrently including testing, special
project / protocol testing.
- Participate in functions involving teams, which impact
production, increase efficiency, generate cost savings, and improve
- Perform review of test data, which includes overall
documentation practices (CGDP). Perform release functions in LIMS
or other computerized systems.
- May prepare monthly quality trend reports.
- Perform laboratory audits. Audit and update plant SOPs.
- Perform test equipment, equipment maintenance and
- Basic laboratory functions, test methods, equipment (including
analytical equipment, autoclaves, incubators, and environmental
monitoring equipment), processes and applicable procedures.
- Laboratory safety including standard precautions and hazardous
and biohazardous chemical handling.What you bring to Takeda:
- Bachelor's Degree in Microbiology or Biological Sciences (with
Microbiology Laboratory) is strongly preferred.
- Minimum 1 year of related experience preferred
- Experience in quality operations, biotechnology, pharmaceutical
or similar GMP manufacturing environment would be ideal
- General knowledge of FDA regulations, application of Good
Laboratory Practices, application of Good Manufacturing Practices
and application of Good Documentation Practices is preferred.
- Wet and instrumental methods of analyses (preferred).
- Can work in a team environment.
- Can work on multiple projects/workflows to meet established
- Has technical problem-solving ability and analytical
- Proficient in multiple mathematical disciplines; including the
use statistical tools would be helpfulWhat 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 and development 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. In this role,
- 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 areas
(Noise above 85 dBA).
- Need to remove all make-up, jewelry, contact lenses, nail
polish and artificial fingernails while in the manufacturing
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work
- Work around chemicals such as alcohol, acids, buffers, Celite,
and Methotrexate, which is a known cell growth inhibitor that may
require respiratory protection.
- Can sit between 3-4 hours, walk between 1-2 hours and stand for
over 4 hours.
- Can bend at the neck/waist, squat and climb (using step stools
and ladders) between 1-2 hours.
- Can reach above/below the shoulder, kneel, twist at the
neck/waist between 1-2 hours.
- Can lift up to 50lbs between 5-10lbs up to 30x per shift,
11-25lbs up to 5x per shift, and 26-50lbs up to 5x per shift.
- Can carry 5-10lbs up to 30x per shift up to 20ft, 11-25lbs up
to 5x per shift up to 5ft, and 26-50lbs up to 5x per shift up to
- Requires repetitive use of both right and left hands over 4
- May require simple/power grasping and pushing/pulling with
hands/arms between 3-4 hours.
- May require fine manipulation up to 1 hour.
- Will not operate foot controls or repetitive foot movement and
work at heights above floor level
- May require the use of special visual, respiratory, or auditory
- May work with biohazards such as: bloodborne pathogens, sewage,
or medical waste.
- May work in confined areas.
- Laboratory environment; inside working conditions.
- 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 require immunization before performing work within the
manufacturing areaMore 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.Base Salary Range: $44,800.00 to
$ 64,000.00. 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 & Vacation, Tuition
Reimbursement Program, and Paid Volunteer Time Off. The final
salary offered for this position may take into account a number of
factors, including, but not limited to, location, skills,
education, and experience.#GMSGQ #ZR1 #LI-1EEO 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 Control Analyst - Microbiology, Professions , Thousand Oaks, California
Didn't find what you're looking for? Search again!
Loading more jobs...