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Quality Assurance Manager I - ...

Monster
 
 
 
 

Job Summary

Company
Takeda
Location
Boston, MA
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4314_R0004070

Quality Assurance Manager I - Technical Operations

About the Job

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Assurance Manager I – Technical Operations in our Deerfield, IL office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Title working on the Quality Assurance team, you will be empowered to ensure the quality of our products are superior for our patients to achieve desired outcomes and a typical day will include:

POSITION OBJECTIVES:

  • Performing quality technical support for commercial drug substance, drug product, and finished goods
  • Focused primarily on providing support and guidance for CMOs regarding routine quality-related issues
  • Serve as Lead Quality liaison subject matter expert for technical support with CMOs

POSITION ACCOUNTABILITIES:

  • Provide Quality Assurance (QA) technical support for commercial lots of oral solid dosage drug substances, products and finished goods
  • Provide technical investigation support in review of deviations and investigations to assess cGMP lot compliance
  • Lead off-site visits and teleconferences in discussion and review of supplier performance and cGMP compliance, providing in person plant assistance as necessary
  • Review/Approve technical change controls as related to drug substance, drug product and finished goods
  • Review/approve controlled cGMP documents including Standard Operating Procedures (SOPs), Material Specifications, Investigation protocols/reports, and Process Validation protocols/reports as applicable
  • Identify, propose, and lead Quality process and system improvements 
  • Serve as QA representative on cross functional project teams such as tech transfer, process validation, and process improvements
  • Review and approve process, assay, and other validation protocols and reports as applicable
  • Review and approve applicable sections of regulatory submissions and provide Global Quality Auditing SME support as necessary
  • Provide support in the evaluation/implementation new technologies
  • Support QA review and disposition of validation/commercial lots of drug substance, drug product and finished goods

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BA/BS (or Master's) in any Life Science discipline preferred, and/or 8+ years’ experience
  • Oral Solid Dosage (OSD), Parenteral and/or Biologic manufacturing knowledge is preferred
  • Demonstrated understanding and application of good working knowledge of quality and GMP principles
  • Ability to handle multiple tasks concurrently and in a timely fashion accompanied by good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals
  • Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
  • Must display eagerness to learn and continuously improve
  • Positive work attitude that supports teamwork and continuous improvement
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction
  • Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint

PHYSICAL DEMANDS:

  • Wrist and hand motion (e.g. typing, writing)
  • Must be able to work in controlled or clean room environments requiring special gowning

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings or client sites, including overnight trips
  • Requires approximately 25% travel

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

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-DB1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
 

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