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Document Associate I

Bannockburn, Illinois

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 2018.

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

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Document Associate I

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Job ID SR0043158 Date posted 10/17/2019 Location Bannockburn, Illinois

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

A subsidiary of Takeda, BioLife is an industry leader in operating high quality plasmapheresis centers throughout the United States. At BioLife Plasma Services, we excel at caring. Caring for the quality of our lifesaving services, caring for the donors who help make it happen, and caring for the communities we call home. Improving Lives. Improving life for everyone.

BioLife’s employment opportunities are among the best, offering competitive pay, immediate benefits, paid time off, on the job training, advancement potential AND an environment full of fast-paced fun all while working to save lives.

OBJECTIVES/PURPOSE

Handle tasks associated with the processing of post donation information, positive test results, and nonconforming reports with minimal supervision.  Provide assistance in preparing, processing, and delivering quality documentation according to regulatory requirements.  Maintain current and archive documentation in accordance with GMP and GDP regulations/practices.

ACCOUNTABILITIES

Facility Support (60%)

Assist in the receipt and review of documentation submitted by plasma collection centers to identify plasma units determined to be unsuitable for further manufacturing

  • Review of documentation to verify accurate donor and/or plasma unit suitability assessment
  • Assist in the preparation of consignee notifications for the recall of plasma units determined to be unsuitable for further manufacturing
  • Ensure ALL Lookback assessments and Consignee notifications occur within required timeframes

Corrective and Preventative Actions (10%)

Assist in the investigation of errors (e.g. TrackWise), including corrective and preventative actions, if applicable

Administrative Support (30%)

  • Manage current and archive filing systems to allow quick and easy access to documentation
  • Revise and create SOPs to improve department processes
  • Assist Lookback Supervisor and/or Lead, Medical Affairs in special projects as assigned
  • Train Lookback staff in required SOPs for job functions as applicable
  • Other duties and responsibilities as assigned

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential:  High School diploma

Desired: Associate degree or equivalent or 3 years or more experience with plasma collection industry

Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:

Leadership Behaviors

  • Integrity
  • Fairness
  • Honesty
  • Perseverance
  • Putting the patient at the center
  • Building trust with society
  • Reinforcing our reputation
  • Developing the business

ADDITIONAL INFORMATION

  • Identify plasma units determined to be unsuitable for further manufacturing
  • Ensure all lookback activities are performed in accordance with BioLife SOPs and federal and foreign regulatory guidance (e.g. FDA and EMA)
  • Consults with Lookback Supervisor and Lead, Medical Affairs on a regular basis (Internal)
  • Contacts plasma collection center employees to resolve questions and issues on a daily basis (Internal)
  • Contacts third party suppliers and customers regarding BioLife and brokered plasma as needed (Vendor/Customer)
  • Ability to work in a fast-paced, high-volume environment performing multiple tasks as part of agoal-oriented team
  • Detail-oriented with ability to detect errors in documentation
  • Ability to read and understand SOPs and GDPs
  • Excellent organizational skills
  • Ability to make decisions based on past experiences, established practices, and procedures
  • Ability to prioritize multiple projects and tasks
  • Strong written, oral, and communication skills
  • Experience creating Excel spreadsheets and PowerPoint presentations
  • Ability to evaluate processes to propose improvements
  • Excellent interpersonal and leadership skills

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0043158

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