Sr. QA Technical Specialist

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 9 days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Senior QA Technical Specialist acts independently and provides QA subject matter knowledge in the GMP domain to systems and projects with focus on key quality activities and deliverables in accordance with company policies/SOPs and regulatory requirements. Works closely with project teams and stakeholders across the organization support development and maintenance of computerized system and data integrity PQS subsystems.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

Major Accountabilities:

Review and approval of validation documentation against PQS subsystems Computerized Systems and Data Integrity processes and requirements.
Review and approval of qualification documentation against PQS subsystems Computerized Systems and Data Integrity processes and requirements.
Review and approval of changes events/deviations incidents CAPAs etc. (process records) as well as procedural documents in relation to computerized systems.
General inspection and audit support in relation to computerized systems.
Develop and maintain the PQS framework related to computerized systems and based on current GMP and other relevant regulatory requirements (per global policies).
Meet internal training requirements (per assigned training curricula) and keep oneself up to date on current GMP and other relevant regulatory requirements as well as relevant guidelines for computerized systems
This position has interactions to Engineering as well as all other QA functions locally and globally.

Education and Experience Requirements:

High School Diploma or Equivalent with12years of applicable industry experienceOR
Bachelors degree with8years of applicableindustryexperienceOR
Masters degree6years ofapplicableindustryexperienceOR
PhDwith4yearsofapplicableindustryexperience
Solid GMP knowledge

Preferred Experience:

QA and/or manufacturing expeirence from the pharmaceutical industry

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

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EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Senior IC

Position OverviewThe Senior QA Technical Specialist acts independently and provides QA subject matter knowledge in the GMP domain to systems and projects with focus on key quality activities and deliverables in accordance with company policies/SOPs and regulatory requirements. Works closely with pro...