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Quality Lead Technician

Company: Takeda
Location: Ames
Posted on: November 29, 2019

Job Description:

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.

Primary Role

Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Takeda Quality System, and other applicable regulations for a plasma center. Is able to perform all technical tasks required within the work areas and will work in these areas as a Master Plasma Center Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician.

All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.

Essential Functions

Responsibilities

  • Performs duties associated with Quality (including but not limited to): (50%)
  • Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements.
  • Tracks deviations in operating procedures and policies through established mechanisms. Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR).
  • Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
  • Ensures SOP's are current and that staff perform routine tasks according to SOP through direct observation.
  • In the absence of a QMR, works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of observations.
  • Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback. (30%)
  • Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (10%)
  • Maintain certification and perform all required duties of MPCT . (10%)

    Education & Experience Requirements

    Essential: High School Diploma or equivalent required

    Desired: Associate or Bachelor's degree preferred

    Key Skills and Competencies

    • A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience.
    • Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician).
    • Completion of all training through Master Plasma Center Technician. Demonstrated understanding of quality assurance in an FDA-regulated environment.
    • Effective communication, organizational, and technical/problem-solving skills.

      Other Job Components

      Complexity and Problem Solving

      • Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
      • Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
      • Refers to management team for escalated donor/employee concerns (internal)

        Internal and External Contacts

        • Reports to Center Manager (Internal)
        • Consults and coordinates directly with the center Quality Management Rep for (internal)
        • Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.

          Other Requirements

          • Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
          • Attend monthly staff meetings and other team meetings as needed.
          • May be responsible to support and conduct other projects as assigned by the QMR or Center Management
          • Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
          • Production environment requiring the ability to walk and stand for the entire work shift.
          • Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee. Requires frequent lifting up to 32 pounds, and occasional lifting up to 50 pounds.
          • Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
          • Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear
          • Other duties and responsibilities as assigned.

            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 -

            EEO is the Law - Supplement -

            Pay Transparency Policy -

            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-###-#### and let us know the nature of your request and your contact information. Associated topics: ascp, hematopathology, lab, medical lab science, medical laboratory science, pathology, services, technician, technician i, toxicology

Keywords: Takeda, Ames , Quality Lead Technician, Professions , Ames, Iowa

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