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Other
high school, associate degree, bachelor degree, postgraduate degree
Medical Insurance, Dental Insurance, Vision Insurance, Prescription Drug Coverage, Health Savings Account, 401(k) Savings Plan
Posted 41d ago
Apply by Jun 29
~40 hrs/week
Responsibilities
Provide quality oversight of day-to-day drug substance manufacturing operations through record review and area inspections. Document findings in the quality system and act as a compliance resource for manufacturing personnel.
Requirements
Requires a high school diploma with 9 years of experience, or a degree (Associate, Bachelor, or Master) with corresponding industry experience (7, 5, or 3 years). Candidates must have fundamental knowledge of cGMP, ALCOA++, and 21 CFR Part 11.
Full job description
Company Overview
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.
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
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!
*#LI-onsite
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.
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 ([email protected]).
Related keywords
cGMPALCOA++GAMP521 CFR Part 82021 CFR Part 11TrackwiseSAPKneatVeevaDrug Substance ManufacturingBiopharmaceuticalQuality AssuranceData IntegrityBatch RecordsFormulation RecordsCell Culture
FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products.
Industry
Chemical Manufacturing
Company size
501-1,000 employees
Headquarters
North Kingstown, RI
LinkedIn followers
8,914
FUJIFILM Electronic Materials develops and manages chemical formulations that power the most critical processes of semiconductor technology. We are a diverse, global supplier that delivers tailored support where our customers need us most. The spirit of partnership drives everything we do — our commitment to the continued success and innovation of our customers is our primary focus. Through state-of-the-art systems, leading-edge technologies, and a commitment to the continuous development of environmentally friendly processes, FUJIFILM Electronic Materials is:
DEDICATED — to the success of our customers and team
CURIOUS — with a genuine interest in finding new ways to innovate
DRIVEN — motivated to push the boundaries of possibility
COLLABORATIVE — committed to working jointly to develop the best solutions
Headquartered in Yokohama, Japan, FUJIFILM Electronic Materials has 11 regional offices globally. As proud members of the FUJIFILM Group, we are one of the leading and most trusted producers of the chemical formulations that enable our partners to progress semiconductor technology to the next node and beyond. Our assured, stable supply is proven through our state-of-the-art quality system. Leveraging leading-edge technologies, our formulations help to power cell phones, computers, medical devices, cars, refrigerators and other goods essential to human life.
The engineers, scientists, manufacturing staff and other professionals who commit their skills and intellect to FUJIFILM Electronic Materials strive to make a difference in their jobs and in the world. Our organization offers the opportunity to pursue challenging and meaningful work in an environment that supports growth. With an internal culture that prioritizes teamwork, open communication and shared success, FUJIFILM Electronic Materials inspires both personal and customer advancement.
Offices: 80 Circuit Drive, North Kingstown, RI 02852, US · 6550 South Mountain Road, Mesa, AZ 85212, US · 1200 W Jackson Rd, Carrollton, Texas 75006, US · 1160 Commercial Pkwy, Castroville, California 95012, US · 250 William White Blvd, Pueblo, Colorado 81001, US
CMP SlurriesCleaners and EtchantsCVD PrecursorsPhotoresistsImage Sensor Color MosaicPhotoresist AncillariesPolyimides and PBO'sHigh Purity Primary SolventsPhotovoltaic Precursorsand Photovoltaic Precursor Equipment
How much do Engineering jobs in North Carolina pay?
Based on 2508 listings with disclosed salaries, most engineering jobs in North Carolina pay between $75k–$183k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in North Carolina right now?
There are currently 8,529 open engineering positions in North Carolina listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in North Carolina?
Companies currently hiring include Corning Incorporated, Eaton, North Carolina Department of Environmental Quality, RTX, Amazon, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in North Carolina?
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