Skip to main content

Search Our Jobs

Sr. Operations & Compliance Specialist

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.

Back to Job Navigation (Overview)

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

Back to Job Navigation (Success)

Back to Job Navigation (Life at Takeda)

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.

Back to Job Navigation (Rewards)

Sr. Operations & Compliance Specialist

Apply Now
Job ID R0033599 Date posted 04/20/2021 Location Social Circle, Georgia

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’sPrivacy Noticeand 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

Under general direction of associate engineering director, the operation & compliance specialist will drive, support, and improve compliance on engineering related activities assigned to the engineering department. Provide engineering support to the operations on day to day investigations, process improvement change control and CAPAS.

Manage and track to completion of change control, CAPAS, beacon, internal and external commitments. Track progress to ensure the plant goals are met on time completion of internal and external commitments. Assess continuous improvement opportunities. Demonstrate effectiveness in task completion, decision making, exception management, training, problem solving and team leadership. Trend, present and drive continues improvement from quality indicators in meetings.  

  • Supervise engineering compliance across multiple department and functions.
  • Manage medium and high-risk exceptions and ensure timely closure.
  • Lead in-plant audit ready status efforts for the engineering department.
  • Manage the initiation, tracing, investigation and completion of documentation and process related exceptions and corrective actions.
  • Lead problem solving and root-cause analysis sessions
  • Manage complex investigations using DMAIC tools
  • Ensure effective implementation of corrective and preventive actions
  • Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects. Trend and present quality indicators for assigned areas in related meetings.
  • Write, review, and manage deviations, SOP, Job Plans and change control documents.
  • Prepare technical review and investigation. Organize data and prepare appropriate documentation for assigned projects.
  • Represent Engineering during Regulatory Inspections/Audit.
  • Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks.
  • Identify and implement improvement initiatives, 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.

Bachelor's degree in Engineering discipline required. 5+ years of related experience. Some leadership experience preferred for supervisory roles.

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 R0033599
Apply NowEmail Me

Back to Job Navigation (Responsibilities)

Explore the Area

Check out where you could be
working if you apply.

View Map