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Operations Specialist I

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Job ID R0047794 Date posted Sep. 22, 2021 Location Social Circle, Georgia

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Job Description

The Operations Specialist I will support the development of a plasma processing facility that will bring the company additional capacity for fractionation, purification, and fill and finish for its biologic medications.


Responsibilities

  • Train staff in general manufacturing activities.

  • Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks.

  • Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls.

  • Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability

  • Stay current with biopharmaceutical industry best practices and technologies.

  • Responsible for organizing data and preparing appropriate documentation including presentation materials for assigned projects.

Investigator

Lead investigations:

  • Lead problem solving and root-cause analysis sessions

  • Interact with Quality, Engineering and Tech Service units

  • Manage complex investigations using DMAIC tools

  • Ensure effective implementation of corrective and preventive actions


Education and Experience Requirements

  • Typically requires Bachelor's Degree, preferably in Science, Engineering or other related technical field. 2+ years of related experience.

  • Minimum two years relevant professional (GMP industry) experience required.

  • Demonstrated ability to performing a high performing workforce.


Other Job Requirements

  • May occasionally work in a clean-room environment and wear special garments (requires removal of make-up and jewelry).

  • May occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas. Company provides PPE.

  • May be required to work weekends, evenings, off-hours, extended periods of time.

Key Skills, Abilities, and Competencies

  • Strong problem-solving and analytical skills are required.

  • Possess knowledge of core manufacturing principles and support systems.

  • Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.

  • Self-driven individual that requires minimal supervision.

  • Must have proficient computer skills and be experienced using MSOffice software (Word,

  • Excel and PowerPoint).

  • Prefer experience with technical writing, reading comprehension, root cause analysis and implementing effective corrective actions.

  • Prefer experience in Track Wise system.

  • Prefer experience in Automation Control Systems, EBM (Electronic batch Record), and

  • PI Historian.

  • Prefer knowledge of Lean Six-Sigma methodology.

  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job posting excludes CO applicants

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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.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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