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Quality Control Analyst - Microbiology at Baxalta U.S., Inc. in Los Angeles, California

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

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 Privacy Notice and 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

About the role:

Perform environmental monitoring of clean rooms and controlled areas to support qualifications and routine sampling of the facility and important utilities including WFI, compressed gas, nitrogen. Conduct microbial based assays including bioburden testing, microbial quantification, and organism identification.

How you will contribute:


  • Perform microbial and particulate monitoring of clean rooms throughout LA facility. Work under some Guidance. 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. 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.

  • Ensure laboratory area is maintained in a GMP state while following all EHS and 5S guidelines. Will do laboratory walk throughs to ensure area is suitable for hand off to oncoming shifts.

  • Contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, create cost savings, improve quality, and provide new product support.

  • Provide training and some work direction for assigned areas.

  • 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.

  • Support execution of validations for lab equipment, lab methods, or facility projects.

  • May execute and summarize special laboratory studies.

  • Guide Lean principles such as 5S throughout daily work activities.

  • Ensure personal training requirements are met and that training records are current.

  • May perform disposal of hazardous waste.

  • Other tasks as assigned by departmental management.

  • 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.

What you bring to Takeda:


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

  • 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.

  • 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.

  • Must be able to work multiple shifts, including weekends.

  • Must be able to work overtime as required (only for non-exempt positions).

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

  • Some Clean Room and cool/hot storage conditions.

  • 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

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs and company match of charitable contributions

  • Family Planning Support

  • Professional training and development opportunities

  • Tuition reimbursement

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.

Location and Salary Information: This post excludes CO applicants

#GMSGQ #ZR1

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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