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Operations Specialist I

Social Circle, Georgia

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Operations Specialist I

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Job ID R0033136 Date posted 04/20/2021 Location Social Circle, Georgia

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Job Description

General

Job Function and Description
• Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs, change controls, etc.)
• 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.

CAPA investigator
• Lead any CAPA 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. Some related experience preferred.
• Professional (GMP industry) experience ideal but not required.

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.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Self-driven individual that requires minimal supervision.
• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).

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.

This job posting excludes CO applicants.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0033136
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