Quality Control Technician I - Takeda : Job Details

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Job Description

About the role:

Conducts and performs a wide range of biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental and critical utility monitoring programs.

How you will contribute:

• Collect samples from manufacturing areas to evaluate environmental classification or critical utility integrity.
• Conduct critical biological, chemical and physical analyses on samples such as raw materials, in-process and final products.
• Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
• Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete all testing, including special project/protocol testing in a timely and appropriate manner.
• May maintain inventory/supplies necessary to conduct routine testing.
• Follow continuous improvement practices (QLP, 5S, LEAN, Standard work, General housekeeping, GEMBA walks etc.)
• Perform document requests, archival and reconciliation as needed.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Follow all safety rules for site and laboratory.
• Complete assigned training on time.
• May perform other duties as needed to support the business needs.
• Able to follow directions.
• Able to identify when proper practices/ procedures are not performed.
• Follow SOPs and generate results.
• Position acts as a support function to manufacturing operations and is required to routinely perform sampling and testing activities. In addition, the individual may correspond with other support functions such as QA, Engineering, Maintenance, etc. Position may be required to participate in interdepartmental teams and communicate with different levels of personnel including management and site leadership.

What you bring to Takeda:

• Typically requires bachelor's degree in chemistry, biological science, or other related technical field. Some related work experience preferred.
• Basic laboratory skills and basic knowledge of statistical method.
• Technical problem-solving skills
• Ability to handle multiple tasks concurrently, and in a timely fashion.
• Must communicate effectively (verbal and written) with supervisors and peers.
• Must demonstrate effectiveness in ability to train others
• Knowledge of most laboratory equipment including but not limited to autoclaves, incubators and analytical equipment.
• Must be proficient in a variety of mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Knowledge of basic chemical and biological safety procedures.
• Good computer skills, knowledge of Microsoft Word, Excel and PowerPoint.

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:

• May lift, push, pull and carry up to approximately 25 lbs.

• May 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. This may include additional hearing protection for loud areas.

• In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.

• Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.

• May be required to work or be assigned to a different shift to meet business needs including weekends and swing shift. Must be willing to work off shifts hours.

• Must be able to work supplemental hours as necessary to complete work commitments.

• May be required to work in a confined area.

• Primarily inside working conditions.

• Some clean room and cool/hot storage conditions.

• Environmental monitoring sampling, critical utility sampling and testing, endotoxin and bioburden testing for raw material, in process, and final container samples, microbial identification.

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

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 - GA - Social Circle - Hwy 278

U.S. Hourly Wage Range:

$14.13 - $22.21

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.

LocationsUSA - GA - Social Circle - Hwy 278

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

No