Fujifilm Manufacturing USA, Inc

QA Engineer - Onsite - Warminster, PA

Fujifilm Manufacturing USA, Inc • $75K — $95K *
Warminster, PA 18974In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 days ago
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Science, Engineering, Technology, or related field
  • 5+ years experience in Quality Assurance
  • Strong understanding of ISO 9001 and GMP requirements
  • Experience with batch records and product release
  • Experience in leading validation activities
  • Proficient in conducting investigations and audits
  • Excellent communication skills in English

Responsibilities

  • Perform incoming inspections and documentation tasks
  • Assist with document creation and revisions
  • Support audits from internal and external parties
  • Review and release raw materials and final products
  • Lead and execute validation processes
  • Manage data reviews and continuous improvement projects
  • Act as customer liaison for inquiries and feedback

Benefits

  • Medical, Dental, Vision
  • Life Insurance
  • 401k
  • Paid Time Off
Full Job Description
Position Overview

Position Description

Onsite Full Time Hours: 8:30am-5:00pm EST

We are hiring a Quality Assurance Engineer. The Quality Assurance Engineer will be responsible for Lead Quality System improvements as well as drive resolution of deviations and product nonconformance. The role involves identifying and implementing efficiencies, leading risk assessments, managing quality-related customer support, and ensuring compliance with ISO 9001 requirements. They will also oversee and ensure that required quality exists in all Quality Assurance & Validation functions as prescribed by the ISO 9001 and applicable standards/regulations.

Job Description

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 Preventative 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.
  • Other duties as assigned.

Required Skills/Education:
  • 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
  • Experience in batch records, raw materials, intermediates, and final products review and release.
  • Experience in leading and executing equipment and process validation activities.
  • Experience in leading and executing investigations, customer surveys, questionnaires, and audits.
  • Ability to speak, write, and read English well.
  • Good oral and written communication skills.

Benefits:
  • Medical, Dental, Vision
  • Life Insurance
  • 401k
  • Paid Time Off

*#LI-onsite

About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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