QA Specialist, Validation

Full-time

FUJIFILM Biotechnologies

Position Overview
The QA Specialist, Validation is responsible for helping to drive the Quality oversight for commissioning and qualification processes. This role is responsible for quality assurance oversight, review, and approval of validation activities and documents associated with new systems, changes to existing systems, maintaining the validated state of equipment/processes/systems, and decommissioning.
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:
Job Description
What You'll Do
Performs a role within the QA team for the development of documents, processes, and procedures for the Validation program.
Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities and equipment are first validated and then maintained in a validated state.
Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities and equipment.
Generates, reviews, and approves QA documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility.
Ensures project and operational quality objectives are met within desired timelines.
Manufacturing (Clean Room) shop floor support for issue resolution, as needed.
Participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections.
Must be flexible to support 24/7 manufacturing facility.
Performs other duties, as assigned.
Knowledge, Skills, and Abilities
Strong verbal and written communication skills to partner with different teams and stakeholders.
Excellent oral and written communications skills and fluency in English.
Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
Ability to think critically and have superior problem-solving skills.
Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
Basic knowledge and application of cGMP compliance and other related regulations.
Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
Occasional opportunity for International and/or Domestic travel may be available.
Minimum Qualifications
Bachelor's degree in Life Sciences or Engineering with 2 years of applicable industry experience; OR,
Master's degree in Life Sciences or Engineering with no previous experience.
1-3 years of experience working in a GMP regulated environment.
Experience in Validation and/or Quality oversight, in an FDA regulated facility.
Preferred Qualifications
Working knowledge and experience with ASTM E2500, Smartsheets, Trackwise, Veeva, and Kneat validation software.
Familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies.
Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.
Understanding of Drug Substance, Drug Product and/or Finished Goods manufacturing processes.
Experience with startup projects or initiatives.
Training and/or familiarity with Quality Risk Management principles.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
Ability to discern audible cues.
Ability to stand for prolonged periods of time for up to 120 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.
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 place. 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.
*LI-Onsite
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 (View email address on us.fitly.work).

Apply

Vacancy posted 7 days ago

Similar jobs that could be interesting for youBased on the QA Specialist, Validation in Holly Springs, NC vacancy

QA Specialist, DSM Operations (Days 2-2-3 / 0600-1800)
...Position Overview The QA Specialist, DSM Operations (Days 2-2-3 0600-1800) is responsible for partnering in the Quality oversight of... ...Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure...
Suggested
Full time
Immediate start
Flexible hours
Shift work
FUJIFILM Biotechnologies
Holly Springs, NC
7 days ago
Quality Assurance Specialist
This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation...
Suggested
Planet Pharma
Holly Springs, NC
2 days ago
Quality Assurance Senior Associate
$30 - $40 per hour
Job Description Job Description Job Title: Quality Assurance Senior Associate Job Description The Quality Assurance Senior Associate will work fully onsite in a shift-based role, partnering closely with manufacturing and support teams to oversee bulk drug substance...
Suggested
Contract work
Temporary work
Work experience placement
Work at office
Shift work
Night shift
Actalent
Holly Springs, NC
13 days ago
Quality Assurance Associate
$24 - $26 per hour
...raw material inspections, samples, and testing areas • Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations... .... Holly Springs, NC $24.00-$26.00 2 days ago Quality Assurance Specialist - cGMP Manufacturing Holly Springs, NC $25.00-$30.15 15 hours...
Suggested
Contract work
Remote work
Planet Pharma
Holly Springs, NC
4 days ago
Quality Assurance Specialist
...established biopharmaceutical company hiring for Quality Assurance Specialists to join their team. This is a direct hire opportunity,... ...has hands-on quality assurance experience performing QA reviews for validation documentation, facility forms and completed inventories. Responsibilities...
Suggested
Accentuate Staffing
Cary, NC
4 days ago
Quality Assurance Specialist
...Quality Assurance (PQA) experience Drug Substance manufacturing experience preferred Experience with batch records, deviations, and QA oversight Previous experience in GMP-regulated facilities (GMP/GNP) Ability to work independently, in teams, and across shifts...
Shift work
SSi People
Holly Springs, NC
2 days ago
Quality Assurance Specialist I
...Job description The Quality Assurance Specialist I is responsible for implementing and... ...requirements. Role and Responsibilities QA review incoming client material and... ...destruction QA review and approve validation documentation and other facility forms...
Work experience placement
Kryosphere
Cary, NC
5 days ago
Quality Document Control Specialist
...Documentation Management: The Document Control Specialist is responsible for maintaining cGMP-... ...drawings (ISOs) with weld logs, validation/commissioning protocols, and Quality reports... ...specifications, government regulations, and InServ’s QA/QC policies and procedures. The Document...
Full time
For contractors
For subcontractor
Local area
Flexible hours
InServ
Fuquay Varina, NC
1 day ago
Quality Control Senior Associate
Fully Onsite Urgent role- shortlisting within 48 hours Candidate musts be available to work on a 4/10 (7:30am - 6pm), Sunday through Wednesday, schedule. Job Summary: The Quality Control Sr. Associate supports QC Sample Management and Stability team within the QC Support...
Merck & Co. Inc
Holly Springs, NC
13 hours ago
Senior Principal Quality Control Specialist, Master Data
$128k - $238k
Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient...
Full time
Local area
Relocation package
Flexible hours
Roche
Holly Springs, NC
5 days ago
Quality Control Senior Associate
$40 - $43 per hour
Title: Quality Control Senior Associate Duration: 12 Months Location: Holly Springs, NC Shift: 10 hours per day, Wednesday‑Saturday, Night Shift | Shift starts at 10 PM. For training, they will begin on the day shift and then transition to the night shift. Key Responsibilities...
Hourly pay
Temporary work
Shift work
Night shift
Day shift
Collabera
Holly Springs, NC
4 days ago
Quality Improvement Specialist
...A manufacturing company in Cary, North Carolina, seeks a Quality Specialist to ensure that all manufactured parts meet quality standards with minimal waste. You will collaborate with design and production teams, conduct inspections and audits, and manage the quality management...
Custom Cylinders Inc
Cary, NC
4 days ago
Quality Specialist
...1(k) 401(k) matching Dental insurance Health insurance Paid time off Parental leave Vision insurance Overview The Quality Specialist is a key member of the Custom Cylinders team, responsible for ensuring that all manufactured parts meet rigorous quality standards...
Custom Cylinders Inc.
Cary, NC
13 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to QA Specialist, Validation. Be the first to apply!