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Job Description

Job Title: Quality Control Technician I

Location: Social Circle, GA

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 monitoring programs. Position may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations.

How you will contribute:

Identified responsibilities include:

• Collect samples from manufacturing areas to evaluate environmental classification or critical utility integrity.

• Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at the company manufacturing facilities, etc.

• 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.

• Initiate and obtain applicable approval for test requests.

• May maintain inventory/supplies necessary to conduct routine testing.

• Follow continuous improvement practices (QLP, 5S, LEAN, etc.)

• Performs equipment maintenance and calibrations as required.

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.

• May perform other duties as assigned.

Complexity and Problem Solving

• Able to follow directions.

• Able to identify when proper practices/ procedures are not performed.

• Follow SOPs and generate results.

Internal and External Contacts

Position acts as a support function to manufacturing operations and is required to routinely coordinate testing activities and communication of results with IG, Fractionation, and Albumin. In addition, the individual will also 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.

Key Skills, Abilities, and Competencies

• Proficient in wet and instrumental methods of analyses.

• Advanced laboratory skills and basic knowledge of statistical method.

• Strong 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.

Other Job Requirements

• 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. 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.

Position may be allocated in QC Analytical, Microbiology, Compliance, QCMIS, and/or Laboratory Operations with general job requirements summarized below:

AQC:

• Wet/dry chemistry or biochemistry test methods, compendial raw material testing, maintenance of associated assay equipment, and reconciliation of test results.

Microbiology:

• Environment monitoring, critical utility sampling, endotoxin testing, bioburden for raw materials and in process, process samples, microbial identification and final product sterility testing.

Compliance:

• Manage and investigation of non-comformance events (OOL, OOS, etc.). Develop and deploy the site Contamination Control Master Plan (CCMP).

QCMIS:

• Development, validation, and optimization of departmental assays.

Laboratory Operations:

• Support laboratory operations through sample control, equipment metrology, data reconciliation/ archiving, or computerized system programming and support.

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 be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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

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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.

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