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Quality Control Analyst II
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Control Analyst II in our Thousand Oaks, CA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
In the QC Microbiology department, the primary responsibilities of the Quality Control Analyst II is to conduct biological or chemical analyses on raw materials, in-process samples, final product samples or samples collected from environmental monitoring programs at Takeda manufacturing facilities.
Essential Duties and Responsibilities
- Use laboratory instrumentation and analytical equipment to analyze test samples. Use computer systems (LIMS) to collect and record data.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
- Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
- Perform review of test data, which includes overall documentation practices (cGDP). Perform release functions in LIMS or other computerized systems.
- Maintain test equipment, equipment maintenance and calibrations as required.
- Manage multiple tasks and have ability to prioritize workload.
- Serve as a mentor to QCA I positions. Provide training, explain processes and assist in providing work direction on complex processes as required.
- Investigate complex non-conformances and write exception documents.
- Apply advanced laboratory skills to perform complex assays including special project/protocol testing in a timely and appropriate manner.
- May perform internal laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
- For internal candidates - expected to demonstrate skills and knowledge of QC Analyst I.
- May perform other duties as assigned.
- Proficient in advanced wet and instrumental methods of analyses.
- Knowledge of laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.
- General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
- Knowledge of laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
- Knowledge of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
- Knowledge of quality systems including exception management, change control, document control, etc.
- Knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and medical device manufacturing labs a plus.
- Ability to write detailed investigation reports that consistently meet the requirements of the Takeda Quality Organization and the expectations of regulatory agencies.
- Knowledge of how to implement investigation strategies and apply root cause failure analysis.
- Must be a solid team player, able to meet deadlines and changing priorities.
- Must be able to communicate effectively with managers, peers and subordinates.
- Must be very detail oriented and able to produce high quality work.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Must have the ability to complete tasks with minimal direction from manager and/or supervisor.
- Must have the ability to prioritize multiple projects/workflow and manage time efficiently to meet established timelines.
- Must have decision-making skills, strong technical problem-solving ability and analytical skills.
- Must be proficient in a variety of mathematical disciplines. Ability to use and apply statistical tools a plus.
- Proficiency with the MS Office suite of programs (including Microsoft Word, Excel and PowerPoint)
Education and/or experience
- High School degree or equivalent required; Bachelor’s Degree in Microbiology or Biological Sciences (with Microbiology Laboratory) is strongly preferred
- Minimum 2 years of related work experience
- Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.
- The overall physical exertion of this position requires light to medium work.
- May be required to sit between 1-2 hours, walk between 3-4 hours and stand for over 4 hours
- May be required to bend at the neck/waist, squat and climb (using step stools and ladders) between 1-2 hours
- May be required to reach above/below the shoulder, kneel, twist at the neck/waist between 1-2 hours
- May be required to 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
- May be required to 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 5ft
- Requires repetitive use of both right and left hands over 4 hours
- May require simple and power grasping between 3-4 hours
- May require fine manipulation up to 1 hour
- May require pushing/pulling with hands/arms between 3-4 hours
- May require office work activities with hands/arms between 3-4 hours in all Quality areas
- May be required to gown frequently and balance when gowning into clean areas
- Will not be required to drive cars, trucks, forklifts or other equipment
- May be required to work around moving equipment and machinery
- May be required to walk on uneven ground or slippery surfaces
- May be exposed to noise above 85 dBA in Microbiology. This may require hearing protection and other protective equipment to be worn.
- May work and have exposure to hot, cold, wet environment/conditions.
- May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes (may require respiratory protection)
- May be required to work at heights above floor level
- Will not be required to operate foot controls or repetitive foot movement
- May require the use of special visual or auditory protective equipment
- May be required to work with biohazards such as: bloodborne pathogens, sewage or medical waste in all Quality areas.
- May be required to work in confined areas.
- Laboratory environment; inside working conditions
- Must wear personal protective equipment due to safety requirements in designated lab areas. May be required to work in controlled or clean room environments requiring special gowning. Will be required to 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 these work environments.
- May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
- May work around Methotrexate, which is a known cell growth inhibitor.
- May require immunization before performing work within the manufacturing area.
- Overtime may be required at times.
- Will be required to work an alternate work schedule (10 hour shift / 4 days a week).
- May be required to work or be assigned to a different shift as needed.
- Maybe required to work weekends and holidays.
- This job posting excludes CO applicants.
EEO Verbiage for US Reqs
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.