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Job DescriptionThis position reports to Night (3) shift. This shift schedule is Monday-Friday from 10 PM to 6 AM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
Perform environmental monitoring of clean rooms and controlled areas to support qualifications and routine sampling of the facility and critical utilities including WFI, compressed gas, nitrogen. Conduct microbial based assays including bioburden testing, microbial quantification, and organism identification.
Responsibilities
Perform microbial and particulate monitoring of clean rooms throughout LA facility. Work under some Supervision. May oversee daily work flow of assigned area.
Test supporting microbial identifications, bioburden analysis, biological indicators, growth promotion, and water groups. Will read microbial plates and interpret test results. Some troubleshooting will be required.
Perform review of test data with application of GDP.
Use Global LIMS or other computerized systems for entering and approving test results.
Will perform change requests (e.g. ECR, DCR) and complete them promptly. Assure SOPs are updated; prepare and update as determined.
Identification and issuance of Alert/OOL forms for out of limit results. May conduct investigations into Alert/OOL excursions.
Provide training and some work direction for assigned areas.
Operate and maintain laboratory equipment. Ensure that equipment maintenance is documented promptly.
Investigate deviations and write exception documents.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
Support execution of validations for lab equipment, lab methods, or facility projects.
Qualifications
Typically requires Bachelor's Degree in Science-Chemistry or Biological Science. 2+ years of experience.
Demonstrated working knowledge of assays/equipment in functional area.
Can demonstrate the ability to guide people, encourage teamwork, and teach assays.
Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs.
Good project management skills.
Physical Demands
Must be able to lift, push, pull 25 lbs and carry up to 50 lbs.
In general, you will have a combination of sedentary work and walking around observing conditions in the facility.
Work Environment
Will work in controlled environments requiring special gowning. Will 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 the manufacturing environment.
Will work in a loud area that requires hearing protection and other protective equipment to be worn.
20/20 near vision required (corrected vision is acceptable).
Will work in a cold, wet environment.
Will work around chemicals such as alcohol, acids, and alkalines that require protective equipment.
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 - Los AngelesU.S. Hourly Wage Range:
$22.55 - $35.43The 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 Statement
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.
LocationsUSA - CA - Los AngelesWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
