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Job Details

Quality Control Analyst- Microbiology

Company name
Takeda Pharmaceutical Company Limited.

Location
Los Angeles, CA, United States

Employment Type
Full-Time

Industry
Chemistry, Sciences, Quality, Biotech, It

Posted on
Jun 28, 2022

Valid Through
Oct 11, 2022

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Profile

Job Description

Location

Business Area Overview

At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma Collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Working at Takeda

Inclusion

Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.

Collaboration

A strong, borderless team, we strive together towards our priorities and inspiring mission.

Innovation

Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

Top Workplace

Recognized for our culture and way of working, we’re one of only 11 companies to receive Top Global Employer® status for 2022.

Work-Life

Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

Empowerment

Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

Quality Control Analyst- Microbiology

Job ID

R0070546

Date posted

Jun. 28, 2022

Location

Los Angeles, California

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Job Description

Shift D (Weekend Swing):

This position reports to Weekend Swing (D) shift. This shift schedule is Saturday and Sunday 10:00 AM to 10:00 PM, plus a third day during the week. This shift requires working on all company designated holidays.

 Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

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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Job Seekers: Protect yourself against identity theft

Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees in an attempt to steal personal information from job seekers. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and personal identification numbers. If you receive unexpected offers of employment from people claiming to work for Takeda, we suggest you do not correspond with them. Do not click any hyperlinks and do not open an attachments.

At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews nor do we charge job seekers fees as part of the recruitment process. Takeda's recruiting correspondence will be sent by a recruiting representative with @takeda.com e-mail address – not @gmail.com, @yahoo.com, @hotmail.com or any other e-mail domain service.

We are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: https://www.consumer.ftc.gov/articles/0497-credit-freeze-faqs;

2) file a complaint with the U.S. Federal Trade Commission: https://www.ftccomplaintassistant.gov/;

and/or 3) file a report with your local law enforcement agency immediately.

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Takeda Pharmaceutical Company Limited.
Website : https://www.takeda.com

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