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Sr. Quality Control Technician at Baxalta U.S., Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Social Circle, Georgia





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:

Conduct and perform many 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. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations .

How you will contribute:

Job Responsibility and Description


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

  • Conduct important 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.

  • Use 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.

  • 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.)

  • Perform equipment maintenance and calibrations. 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..

What you bring to Takeda:

Education and Experience Requirements

  • Typically requires bachelors' degree in science, engineering or other related technical field. (x+) years of related
Key Skills, Abilities, and Competencies

  • Proficient in wet and instrumental methods of analyses.

  • Advanced laboratory skills and basic knowledge of statistical method.

  • Technical problem-solving skills

  • Must communicate effectively (verbal and written) with supervisors and peers. • Must demonstrate effectiveness in ability to train others

  • Knowledge of most laboratory equipment including autoclaves, incubators and analytical equipment.

  • Must be proficient in many mathematical operations and calculations and be able to work with both the metric and US standards of measurement.

  • Will read and follow detailed written instructions.

  • Knowledge of basic chemical and biological safety procedures.

Complexity and Problem Solving
  • Able to identify when proper practices/ procedures are not performed. • Follow SOPs and produce results.
Internal and External Contacts

Position acts as a support function to manufacturing operations and is required to coordinate testing activities and communication of results with IG, Fractionation, and Albumin. Also, you will also correspond with other support departments such as QA, Engineering, Maintenance. You may participate in interdepartmental teams and communicate with different levels of personnel including management and site leadership.

Other Job Requirements


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

  • May work in controlled environments requiring special gowning. You will 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, your work will be 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 work or be assigned to a different shift to meet our needs. Must be willing to work off shifts hours.

  • Will work supplemental hours as necessary to complete work commitments.

  • May work in a confined area. Primarily inside working conditions.

  • Some clean room and cool/hot storage conditions.

You may be allocated in QC Analytical, Microbiology, Compliance, QCMIS, and 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 reconcilitation of test results. Microbiology:

  • Environment monitoring, important 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 nonconformance 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.

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

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. You may:


  • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

  • Need to remove all make-up, jewelry, contact lenses, nail polish 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.

  • 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.

This posting excludes Colorado applicants.

#GMSGQ

#ZR1

#LI-MA1

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 - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





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