Quality Control Technician I

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Job Description

About the Role :

Responsible for coordination (pick-up, receipt, aliquot, distribution and shipping) of in-coming bulk, intermediate, final containers, final package, stability and validation samples. Perform data entry and data collection. Perform daily lab support activities (e.g. material, supply and chemical inventory and replenishment, kitting, glassware washing, autoclaving, depyrogenation of labware, biohazardous waste removal and QC Documentation Control) to ensure availability of samples, materials and documentation for QC Labs to meet operational testing turnaround times using Lean Principles. Review and revise documents as needed. Emphasis on continuous improvement and cost effectiveness in daily activities.   Participate and / or drive completion of responsible tasks and improvement projects.

This position will operate during the weekends and include an additional rotating weekday (12-hour shifts).

How you will Contribute :

Pick up, receive, aliquot, and distribute samples to the appropriate laboratories for testing by following SOP and using GMP / GDP / LIMS.

Support in troubleshooting of issues as they arise from daily tasks, such as sample management, documentation management, inventory management and other lab support activities.

Perform lab support activities such as supplies inventory management, supplies ordering and replenishing, managing services requests for Lab equipment, kitting, glassware washing, depyrogenation of labware, autoclaving, and lab wastes removal.

Ship samples to external laboratories for testing in a timely and accurate manner.

Use Global LIMS or other computerized systems for sample receipt, data entry and data approval.

Responsible for managing laboratory documentation including the creation, issuance, and archiving of test data packets, test requests, and other QC related documentation.

Actively contribute to a team setting within the laboratory and potentially work with other work teams to drive continuous improvement such as, increasing process efficiency, problem solving, generating cost savings, improving quality compliance, and providing support to new product or process.

Follow basic lab procedures to assist with general laboratory procedures including but not limited to preparation of solvents, buffers, reagent solutions, measuring and dispensing of solid and liquid chemicals and raw materials.

Perform pipette verification for critical assays and document results in the corresponding form.

Revise and review SOPs and Forms.

Ensure laboratory area is maintained in a GMP and GLP state at all times while following all EHS,lean and regulatory guidelines.

Operate laboratory equipment. Ensure that equipment maintenance and operation history is properly documented in a timely manner.

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

Follow Lean principles such as Just in Time Supply replenishment and 5S throughout daily work activities.

What you bring to Takeda :

High school diploma or GED.  1+  years of related experience or AA (or equivalent) or higher with no prior experience required.

Familiarity with cGMP / GDP and general FDA regulations is preferred.

Ability to complete tasks in a timely manner and take on additional assignments as needed.

Good teamwork and communication with internal and external customers

Good organizational and time-management skills.

Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office).

Must be detail-oriented, conscientious, and responsible.

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 :

Must be able to lift, push, pull and carry up to 40 lbs.

20 / 20 near vision required (corrected is acceptable).

In general, the position requires a combination of walking to pick up samples from various sample collection locations in manufacturing throughout the day as well as performing inventory, stocking, dishwashing, autoclaving etc. of laboratory materials.  There may be some sedentary work as assigned.

Must be able to work in controlled environments requiring special gowning. Will be required to 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 cold and / or wet environment.

Must be able to work multiple shifts, including weekends.

Non-Exempt Roles only : Must be able to work overtime as required.

May be required to work in a confined area.

Some Clean Room and cool / hot storage conditions.

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-Onsite

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 Angeles

U.S. Hourly Wage Range :

$16.97 - $26.65

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. 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.

Locations

USA - CA - Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No