Analyst, QA PQS

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The QA Analyst PQS assists in the quality oversight of PQS applications for the Enterprise Quality Systems administration and document control. The QA Analyst PQS collaborates within the team as well as with other project teams on-site and with QA departments at other FDB sites. This role focuses on consistent policy administration assists QA oversight of daily activities and resolves or mitigates issues that occur during operations. This role maintains relationships with site-based customers and global colleagues and provide updates as requested.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

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

What Youll Do

Supports QA for project deliverables in accordance with the governing processes and procedures within the assigned Quality area
Participates in assigned audits on a regular basis
Identifies evaluates and owns continuous improvement opportunities for the assigned quality area
Maintains quality oversight of quality systems owned by the assigned quality area
Generates reviews and approves QA documentation procedures and processes for operational readiness and through cGMP operations
Uses discretion to make informed quality related decisions for the quality systems area
Actively supports quality decisions that may impact operations ensuring appropriate escalation
Applies knowledge and skillset to be SME for support functionality such as Tableau
Monitors procedures and reports and processes
Documents and communicates areas of concern deviations CAPA etc
Participates in risk assessments and assists in mitigating quality-related risks
Provides administrative support for quality systems as required
Performs other duties as assigned

Minimum Requirements:

Bachelors Degree in Life Sciences (e.g. Engineering Applied Science or Chemistry) with 0-1 years of experience
Basic experience or understanding of GMP GLP GDP requirements

Preferred Requirements:

Prior experience in GMP environment
Previous quality systems experience

Working Conditions & Physical Requirements:

Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. X No Yes

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.

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:

Position OverviewThe QA Analyst PQS assists in the quality oversight of PQS applications for the Enterprise Quality Systems administration and document control. The QA Analyst PQS collaborates within the team as well as with other project teams on-site and with QA departments at other FDB sites. Thi...