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Quality Control Analyst II

4 months ago

Thousand Oaks, California, United States Takeda Full time

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'sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Quality Control Analyst II

Location: Thousand Oaks, CAAbout the role:

As a QC Analyst II, 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. You will report to the HPLC Lab Supervisor.How you will contribute:

Conduct biological, chemical, and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring.Investigate nonconformances and write exception documents.Handle multiple tasks concurrently including testing, special project / protocol testing.Perform review of test data, which includes overall documentation practices (CGDP). Perform release functions in Laboratory Information Management System or other computerized systems.May prepare monthly quality trend reports.Perform laboratory audits and updates, plant SOPs.Perform test equipment, equipment maintenance and calibrations.Laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.Laboratory safety including standard precautions and hazardous and biohazardous chemical handling.Wet and instrumental methods of analyses.Operate and troubleshoot procedures for lab equipmentGeneral knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices would be ideal.Knowledge of quality and regulatory requirements important to pharmaceutical manufacturing labs would be ideal.Write detailed investigation reports, knowledge of how to implement investigation strategies and apply root cause failure analysis would be ideal.What you bring to Takeda:High School degree or equivalent required; Bachelor's Degree in Chemistry, Microbiology or Biological Sciences would be ideal.Minimum 2 years of related work experience.Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment would be ideal.Important Considerations At 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, you may: The overall physical exertion of this position requires light to medium work.May be required to sit between 3-4 hours, walk between 1-2 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 exposed to noise above 85 dBA. 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 conditionsMust wear personal protective equipment due to safety requirements in designated lab areas.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 areas.Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.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.May be required to work or be assigned to a different shift as needed.May be required to work weekends and holidays.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-CA 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 - Thousand Oaks - Rancho ConejoU.S. Hourly Wage Range:$ $35.43 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.S. based employees may be eligible for short-term incentives. 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. 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.Locations USA - CA - Thousand Oaks - Rancho Conejo Worker Type Employee Worker Sub-Type Regular Time Type Full time