Specialist, Quality Assurance

FUJIFILM Biotechnologies; Milwaukee (WI); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Health and welfare benefits

401(k) with company match

Paid vacation and holidays

Employee assistance programs

Job summary

FUJIFILM Biotechnologies is seeking a QA Operations Specialist to provide quality oversight of day‑to‑day Drug Substance Manufacturing operations. This role emphasizes review of records, data integrity, and ensuring area readiness, with a focus on documentation and compliance across manufacturing shifts.

The ideal candidate will possess strong communication and time management skills, familiarity with cGMP and 21 CFR Part 820/11, and the ability to work in a fast‑paced, collaborative

Qualifications

• Oversight of manufacturing records and data for QA compliance.
• Experience with cGMP regulations and related guidelines.
• Ability to interpret SOPs and apply them across tasks.
• Knowledge of cell culture, fermentation, recovery or downstream processes.

Responsibilities

• Review batch and formulation records for compliance.
• Audit electronic audit trails and identify anomalies.
• Provide facility quality oversight including area readiness and changeover confirmations.
• Act as quality resource for manufacturing personnel and documentation.
• Document findings in the quality system and support resolution.
• Manage workflows to meet timelines and escalate if off‑track.
• Perform additional duties as assigned.

Skills

Communication skills

Time management

English fluency

cGMP knowledge

SOPs understanding

GAMP5/ALCOA/Data Integrity/21 CFR

Cell culture/bioprocess understanding

Team collaboration

Genki culture

24/7 manufacturing support

Education

Bachelor's degree in Life Sciences

Master's degree in related field

Tools

Trackwise

SAP

Kneat

Veeva

Job description

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life‑impacting projects alongside today’s 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, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s 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.

Overview

The QA Operations Specialist is responsible for providing quality oversight of the day‑to‑day manufacturing operations for Drug Substance Manufacturing. This is primarily achieved through record and data review, area inspection, and incident resolution.

External US

Major Accountabilities

• Reviews executed batch and formulation records, ensuring production activities were performed as required and documentation meets requirements.
• Reviews electronic audit trails for manufacturing instruments and equipment, identifying orphan data and other anomalies.
• Provides compliance oversight of the manufacturing facility, including area inspections and changeover confirmations.
• Acts as quality resource for manufacturing personnel, especially pertaining to documentation and area readiness.
• Documents findings in the quality system and supports resolution.
• Manages assigned workflows to ensure all required timelines are met and escalates if work is off‑track.
• Performs other duties as assigned.

Minimum Education And Experience Requirements

• High School Diploma or Equivalent with 9 years of applicable industry experience OR
• Associates degree with 7 years of applicable industry experience OR
• Bachelor's degree with 5 years of applicable industry experience OR
• Master's degree with 3 years of applicable industry experience

Knowledge, Skills Or Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders
• Strong time management skills: ability to meet tight deadlines and ensure effective prioritization of tasks
• Excellent oral and written communications skills and fluency in English
• Fundamental knowledge and application of cGMP compliance and other related regulations
• Ability to understand complex SOPs/policies, and apply them appropriately in a variety of tasks
• Awareness of GAMP5, ALCOA++, Data Integrity, and application of 21 CFR Part 820 and Part 11
• Understanding of cell culture, fermentation, 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
• Must be flexible to support 24/7 manufacturing facility

Preferred Education And Experience Requirements

• Experience with Trackwise, SAP, Kneat and/or Veeva

Working Conditions & Physical Requirements

• Will work in environment which may necessitate respiratory protection
• Ability to stand for prolonged periods of time
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to sit for prolonged periods of time.
• Ability to stand for prolonged periods of time.
• Ability to conduct work that includes moving objects up to 10 pounds.

Benefits

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life‑work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

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]).