QA Engineer, Quality Risk Management

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The QA Engineer Quality Risk Management drives the design implementation and continuous improvement of risk-based quality systems across the product lifecycle. The role facilitates structured risk assessments (e.g. FMEA HACCP) translates risk outputs into controls verification/validation plans and monitoring strategies and maintains risk registers and quality risk metrics. It partners cross-functionally with Manufacturing/Operations Supply Chain and Regulatory to enable compliant data-driven decisions effective change control and prioritized CAPA. This position exists to proactively identify quantify and mitigate quality risks to safeguard patient/customer safety ensure product reliability and maintain compliance with applicable standards and regulations (e.g. ISO 9001/13485 ICH Q9 ISO 14971).

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

Leads and facilitates Quality Risk Management (QRM) assessments and workshops to identify analyze and address key quality risks/issues; ensures timely escalation and effective risk handling.
Identifies and assesses risks across operations designs mitigation strategies prioritizes risk actions and communicates progress and outcomes at defined stage gates to drive timely decisions.
Builds relationships and initiates cross-functional collaboration with key counterparts and stakeholders across FLBN to surface quality risks and define process improvement initiatives.
Collaborates with and provides direct support to Manufacturing Facilities Supply Chain QC Laboratory Testing and other stakeholders to implement and sustain QRM processes within established work practices.
Ensures consistent application of QRM system requirements in alignment with local/global procedures policies and applicable regulatory standards (e.g. cGMP).
Prepares and delivers comprehensive reports on QRM activities; maintains risk registers and quality risk metrics to enable transparent data-driven decision-making.
Creates and maintains procedures work instructions forms templates and related QRM documentation to standardize practices and enhance compliance.
Manages multiple QRM projects concurrently balancing scope priorities and timelines to meet deliverables.
Promotes a strong Quality Culture by reinforcing cGMP principles and best practices across departments.

Minimum Requirements:

BS/BA in Life Sciences or Engineering or equivalent with 5 years of applicable industry experience OR
MS in Life Sciences or Engineering and 3 years of applicable experience OR
PhD in Life Sciences or Engineering and 1 years of applicable experience
3 years of experience in a GMP environment
Experience in Validation cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.
High level of familiarity/understanding of validation of production equipment hygienic utilities quality systems automation manufacturing & IT Systems and methodologies

Preferred Requirements:

Experience and working knowledge of ASTM E2500 Smartsheet Trackwise MasterControl and/or Kneat validation software
Experience with startup projects or initiatives

Working Conditions & Physical Requirements:

Ability to ascend or descend ladders scaffolding ramps etc. x No Yes
Ability to stand for prolonged periods of time. No x Yes Daily up to 120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to sit for prolonged periods of time. No x Yes Daily up to 120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers. No x Yes
Ability to operate machinery and/or power tools. x No Yes
Ability to conduct work that includes moving objects up to X pounds. No x Yes If yes x 10 lbs. 33 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. 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 Engineer Quality Risk Management drives the design implementation and continuous improvement of risk-based quality systems across the product lifecycle. The role facilitates structured risk assessments (e.g. FMEA HACCP) translates risk outputs into controls verification/valid...