Validation Associate II

Takeda-posted 4 months ago
$70,000 - $110,000/Yr
Full-time • Entry Level
Riverwoods, IL
5,001-10,000 employees
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BioLife Plasma Takeda offers 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. Every day at BioLife, 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. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. Every day, our BioLife Testing Laboratories’ mission is to ensure the highest quality testing standards for the plasma we collect. The plasma our centers collect will become life-changing medicines for patients in need. Here, a commitment to lab testing quality, customer service to our plasma centers, and most importantly, our commitment to our patients is expected. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

  • The development and completion of documentation on protocols, including test cases and final reports.
  • Manage documents and follow up on validation projects, including new equipment selection, acquisition, installation, and use, facility/system/process improvements, modifications, and additions, and computer-based systems and software.
  • Organizes and performs the logging and archiving of validation documents.
  • Assist in the creation of validation protocols and requalification programs.
  • Coordinate/perform the test activities necessary to execute the validations.
  • Review/summarize the results and conclusions of the validations.
  • Coordinate any software control activities used in the manufacture, testing, approval, or documentation of the product.
  • Performing technical failure analysis on processes/products not meeting specifications.
  • Developing statistical process control programs to monitor processes.
  • Reporting on trends to reduce product/process variability.
  • Apply statistical analysis and design of experimental approaches to process development activities.
  • Works on moderate to complex problems where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • May determine methods and procedures for new assignments and may provide guidance to lower-level personnel.
  • Stays current with federal, state, local, company-specific all other applicable regulations.
  • Provides interpretation and application of regulatory requirements concerning validation activities.
  • Participates in audits of laboratory operations, documents audit findings, and reports results to Laboratory Quality Assurance Manager and Director of Laboratory Operations.
  • Works with the laboratory management team to prepare for and host internal and external auditors.
  • Assists the laboratory management team in ensuring the timely closure of audit observations.
  • Assists with and/or advises on laboratory procedure development and implementation as requested or necessary to support continuous improvement.
  • Performs annual review and or validation of SOPs as needed.
  • Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system regulations and standards in order to effectively perform laboratory quality assurance functions.
  • Maintains current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
  • Performs revisions to Standard Operating Procedures as assigned.
  • Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence goals.
  • Bachelor's degree from an accredited college/university in a biomedical or technical discipline (Chemical, physical, biological, clinical lab science, medical technology, engineering, computer science, or mathematics).
  • Minimum of two years professional or technical experience in a laboratory, blood services, or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.
  • Experience writing/approving validation plans preferred.
  • Familiarity with quality assurance and regulated disciplines in a blood bank setting or a pharmaceutical manufacturing environment is preferred.
  • Prior experience with auditing and/or inspection processes preferred.
  • Knowledge of Laboratory Information Management Systems (LIMS) validation preferred.
  • Bachelor's degree from an accredited college/university in medical technology.
  • Medical, dental, vision insurance
  • 401(k) plan and company match
  • Short-term and long-term disability coverage
  • Basic life insurance
  • Tuition reimbursement program
  • Paid volunteer time off
  • Company holidays
  • Well-being benefits
  • Up to 80 hours of sick time per calendar year
  • Up to 120 hours of paid vacation for new hires
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