Posted to MedZilla on 2/21/2018


Takeda Pharmaceuticals

US-MA, Quality Assurance Specialist III, Oncology and Biologics 1800255-MZ


 
 

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 Specialist III, Oncology and Biologics in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Assurance Specialist III working on the Quality Assurance team, you will be empowered to represent Takeda in managing lead and support project activities, investigations, and other quality systems as they relate to commercial manufacturing, ensuring that quality culture is maintained. A typical day will include:

POSITION OBJECTIVES:

  • The Quality Assurance Specialist III will lot review/release activities for commercial drug substance, drug product and finished goods manufactured by Contract Manufacturing Organizations on behalf of Takeda Boston Oncology & Biologics. This includes: review of executed batch records, maintenance of Master Batch Records, and providing support for change control, and support for regulatory inspections and GMP audits.

POSITION ACCOUNTABILITIES:

  • The QA Specialist III will maintain sufficient expertise in one or more QA disciplines to independently perform analysis and draw appropriate conclusions.
  • Responsible for communications with management and other stakeholders internal to ensure communication of outcomes.
  • Responsible for participating in departmental projects for process improvement and other projects as assigned by their manager.
  • Responsible for actively participating in group training. Positively influences peers in achieving operational and project initiatives and objectives and serves as a recognized technical and procedural resource for peers.
  • This person will be responsible for coordinating/performing assigned investigations including drafting excursion reports for review.
  • Able to identify complex problems and consistently propose solutions. Reviews goals and plan regularly and realign priorities consistent with organizational shifts. Continually seeks creative process improvements.
  • Actively integrates big picture understanding into all interactions. Drives team cooperation and credibility focusing on positive results. Encourages communication, cooperation and win/win solutions.
  • Responsible for coordinating activities to administer assigned tasks. May coordinate activities cross functionally.
  • Influences others to focus on goal attainment by actively generating solutions to wide range of challenges.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelor degree and four (4) years experience in Quality Assurance or related compliance experience or MS and two (2) years Quality Assurance experience (experience may be substituted for degree).
  • At least two (2) years floor experience in a pharmaceutical manufacturing facility under a GMP environment.
  • Solid understanding of applicable regulations and guidance with ability to demonstrate expertise of department processes, tools and methods.
  • Ability to handle multiple tasks concurrently and in a timely fashion.
  • 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 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.
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips.
  • Requires approximately 0-10% 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.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.



Schedule
Full-time


Please visit our website at takedajobs.com

 
 


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