Quality Control Analyst I Microbiology

  • Full time
  • USA - CA - Los Angeles

Hiring company: Takeda

LOCATION: Los Angeles, CA (Glendale)

SCHEDULE: 2:00 PM - 10:30 PM (Monday through Friday)

ABOUT THE ROLE:

You will 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. Join Takeda as a Quality Control Analyst where you will report to the Supervisor of Microbiology and work along side other experienced Analyst.

HOW YOU'LL MAKE A DIFFERENCE:

  • Perform microbial and particulate monitoring of clean rooms throughout the facility

  • Perform testing to 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 and document data using GDP

  • Use Global LIMS or other computerized systems for entering and approving test results

  • Will perform change requests (e.g. ECR, DCR). Assure SOPs are updated; prepare and update as determined

  • Identification and issuance of Alert/OOL forms for out of limit results. May be asked to conduct investigations into Alert/OOL excursions

  • Operate and maintain laboratory equipment. Ensure that equipment maintenance is documented

  • Investigate deviations and write exception documents

  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations

  • Help complete validations for lab equipment, lab methods, or facility projects

  • May be asked to produce and summarize special laboratory studies

  • Promote Lean principles such as 5S throughout daily work activities

WHAT YOU BRING TO TAKEDA:

  • Have a working knowledge of assays/equipment in functional area

  • Able solve technical, compliance, or operational problems

  • Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs

  • Typically requires bachelor's degree in chemistry, biological science, or other related technical field with some related work experience

  • 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

  • May 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 around chemicals such as alcohol, acids, and alkaline that require protective equipment

  • Can work different shifts, including weekends and overtime

  • May be asked to work in a confined area. Inside and Outdoor working conditions

  • Some Clean Room and wet/cool/hot storage area

  • Perform removal of hazardous waste

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 health screenings

  • Paid time off for vacation, sick leave, and volunteering

  • Community Outreach Programs and company match of charitable contributions

  • Family Planning Support

  • Professional development opportunities

  • Tuition reimbursement

MORE ABOUT US:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and outstanding patient support programs. Takeda is a patient-focused company that inspires and empowers 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 provide Better Health and a Brighter Future to people around the world.

This post excludes CO applicants

#GMSGQ

#ZR1

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.

Empowering our people to shine:

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.

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.

Locations

USA - CA - Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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