QA Specialist, Drug Substance Manufacturing

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Specialist for Drug Substance Manufacturing (DSM) to oversee QA activities and ensure validated state of DSM processes. The role focuses on validation program execution and policy administration within a cGMP facility.

Responsibilities include batch/solution review, deviation response, changeovers, and real-time QA support. Strong communication in English and willingness to collaborate globally are essential.

Qualifications

• BS/BA in Life Sciences or Engineering with 2+ years of relevant GMP experience.
• MS in Life Sciences or Engineering with 0 years of relevant experience.
• 1-3 years’ experience in a GMP environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.

Responsibilities

• Provide QA oversight of DSM operations per governing processes and procedures.
• Review Batch Records and Solution Lot Records with exception-based oversight.
• Triage real-time events and implement immediate responses to deviations.
• Support area changeover and return-to-service activities.
• Contribute to QA documentation, procedures, and processes for operational readiness.
• Collaborate with other FUJIFILM Biotechnologies sites on efficiency initiatives.
• Perform other duties as assigned.

Skills

QA oversight

GMP compliance

cGMP lifecycle

Communication

Time management

Team collaboration

Deviations triage

Documentation

Education

BS/BA in Life Sciences or Engineering

Masters in Life Sciences or Engineering

Tools

TrackWise

MasterControl

Kneat validation software

Smartsheet

Job description

Position Overview

The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, DSM Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

Company Overview

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

We’re 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 we’re proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures.
• Provides QA support of DSM tasks such as
  • Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool
  • Real time event triage and implementation of immediate response to identified deviations
  • Area changeover and return to service
  • Real time WO oversight per applicable procedures
• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs.
• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Biotechnologies sites.
• Perform other duties, as assigned.

Knowledge, Skills, and Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Basic knowledge and application of cGMP compliance and other related regulations.
• Excellent oral and written communications skills and fluency in English.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 required.
• Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes.
• Team based attitude and ability to build relationships and communicate effectively with others.
• Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
• Occasional opportunity for International and/or Domestic travel may be available.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience;
• OR,
• Masters in Life Sciences or Engineering or equivalent with 0 years’ relevant experience.
• 1-3 years’ experience in a GMP environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.

Preferred Qualifications

• 2+ years of experience in GMP Quality Assurance and/or similar role.
• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software.Training and/or familiarity with Quality Risk Management principles preferred.

Physical Requirements:

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time for up to 30 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.

EEO Information

Fujifilm is committed to 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 ([e-mail]).