Quality Assurance Specialist

1 week ago


Warminster Pennsylvania, United States Fujifilm Full time
Quality Assurance Engineer

Fujifilm Irvine Scientific, Inc. is a global leader in the development and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. Our company provides unparalleled service and quality to scientists working in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology, and cytogenetics, as well as industrial cell culture for the large-scale production of biotherapeutics and vaccines.

Job Summary

We are seeking a highly skilled Quality Assurance Engineer to lead Quality System improvements and drive resolution of deviations and product nonconformance. The successful candidate will identify and implement efficiencies, lead risk assessments, manage quality-related customer support, and ensure compliance with ISO 9001 requirements.

Responsibilities
  • Perform and assist with incoming inspection, batch records, documentation, training, batch release, validation, deviation, complaint, investigation, continuous improvement, and system reviews.
  • Assist with document creation, revision, issuance, and training.
  • Support internal, customer, supplier, and regulatory audits.
  • Review and release raw materials, intermediates, and final products.
  • Lead and execute validation activities.
  • Manage trend reviews, data reviews, KPI management, and continuous improvement projects.
  • Assess, investigate, and verify information related to non-conformances.
  • Drive continuous improvement within the organization, particularly concerning non-conformance, CAPA (Corrective and Preventive Actions), audit observations, complaints, and other quality datasets.
  • Act as customer liaison for internal inquiries and provide the voice of the customer.
  • Coordinate and complete customer surveys, questionnaires, and audits.
  • Support supplier questionnaires and qualifications.
  • Support change notifications and supplier management.
Requirements
  • Bachelor's degree in science, engineering, technology, or a related field.
  • Minimum of 5 years of experience in quality assurance.
  • Strong understanding of ISO 9001 and GMP requirements.
  • Excellent problem-solving and analytical skills.
  • Strong communication and interpersonal skills.
  • Detail-oriented with a strong focus on quality and continuous improvement.
Desired Skills
  • Statistical Analysis
  • Process Improvement
  • Project Management

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability, exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.



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