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Quality Assurance Specialist II

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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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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Quality Assurance Specialist II

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Job ID R0035441 Date posted 04/22/2021 Location Social Circle, Georgia

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Assurance Specialist II in our Covington , GA office

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

Description:

Summary:

The position will support the operation of a new, state-of-the-art plasma fractionation facility that will bring Takeda additional capacity for testing, purification and fill finish for its biologic medications.

Responsible for timely release of production lots for fractionation, IG and albumin.

Responsible for providing Quality Assurance support to manufacturing process as needed. Provides Quality oversight of operation activities, review batch related document.  Use of Electronic Batch Management (EBM) system.  Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices.   Interacts frequently with functional peer, and provide coaching, training and development of subordinates. The incumbent will demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, and problem solving. 

Essential Duties and Responsibilities:

  • Perform QA Release Function:
    • Complete product C of As
    • Release production lots based on product specifications
    • Update metrics biweekly
    • Maintain task Tracker
    • Follow up with supporting departments on deliverables
    • Identify and escalate issues
  • Perform product holds, tagging and un-tagging of non-conforming material in a timely manner
  • Review documentation for accuracy and compliance to procedures, and release and reject as appropriate.
  • Review electronic  batch records, identify nonconformance’s and participate in investigation and Corrective and Prevention Action(CAPA) activities
  • Provide training and coaching to local employees and others as needed on relevant area(s). 
  • Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Promote continuous improvements through participation (i.e. team leader/facilitator or major contributor) in the Quality Improvement Program.
  • Participate in QA multi-site projects in the role of contributor, coordinator or lead.
  • Other duties, tasks or projects as assigned.

Working Environment:

  • Will be working 8 hour on 1st shift
  • May be required to travel to local and international work locations for extended periods of time for training.

Qualifications:

Education and/or Experience:

BS in Science / Business or equivalent.  3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry.

  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be a team player with good problem solving, and good verbal and written communication skills.
  • Must have the ability to encourage teamwork and drive decisions.
  • Must be able to handle multiple projects concurrently.
  • Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint required
  • Knowledge of TrackWise, Delta V and Electronic Batch Record Management preferred  
  • Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • 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

Empowering Our People to Shine

Discover more at takedajobs.com

This job posting exclude Colorado applicants

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0035441
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