Quality Lead Technician

Overview

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Job Description

Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.

About Bio Life Plasma Services. Every day at Bio Life, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.

Bio Life Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

• 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 Shire Quality System, and other applicable regulations for a plasma center. Acts as Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician.
• Performs all duties in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to proper day-to-day activities. Maintains complete and accurate records in accordance with cGMP.
• Reviews operational records to ensure tasks are complete, accurate, and compliant with cGMP requirements.
• Tracks deviations in operating procedures and policies; reports errors, deficiencies, discrepancies, and observations to center management and Quality Management Representative (QMR).
• Conducts monthly quality assurance audits for critical control points and key elements related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training.
• Ensures SOPs are current and that staff perform routine tasks according to SOPs through direct observation.
• In the absence of a QMR, collaborates with the management team to prepare for and host internal auditors and external inspectors; assists center management 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.
• Provide leadership and training assistance in support of center management and supervisory teams, including oversight of operational flow.
• Maintain certification and perform all required duties of Lead Technician.

• Technical/Functional (Line) Expertise: 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 Lead Technician. Demonstrated understanding of quality assurance in an FDA-regulated environment.
• Effective communication, organizational, and technical/problem-solving skills.
• 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).
• Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
• Ability to read and follow Standard Operating Procedures (SOPs) and maintain complete and accurate records.
• Education:
  
  Essential:
  High School Diploma or equivalent required. Desired:
  Associate or Bachelor’s degree preferred.

• FLSA Classification (US) - Non-Exempt.
• The compensation and benefits details below are provided for the…