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FUJIFILM Diosynth Biotechnologies ยท 2 days ago
QA Engineer (Upstream)
Holly Springs, NC
Contract
Hybrid
Senior Level
6+ years exp
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Responsibilities
Perform an SME role within the QA Team for the development of documents, processes, and procedures for the DSM program.
Assess the impact of system and process modifications and maintain oversight of change management processes to ensure Manufacturing systems are validated and maintained.
Provide oversight and approval of system and process lifecycle documentation including risk assessments, specifications, validation plans, and reports.
Generate, review, and approve QA procedures for the validation approach and lifecycle documents for manufacturing systems.
Generate, review, and approve QA documentation procedures and processes for operational readiness objectives and QA support of manufacturing operations in a cGMP facility.
Ensure project and operational quality objectives are met within desired timelines.
Collaborate with other Fujifilm Diosynth Biotechnologies sites to streamline processes and support regulatory inspections.
Participate in optimization or improvement initiatives and support regulatory agency and third-party inspections.
Perform other duties as assigned.
Qualification
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Required
6+ years of applicable industry experience
3+ years of experience in GMP Quality Assurance and/or Similar role
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 & methodologies
Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11
Excellent Oral and Written communication skills and fluency in English
BS/BA in Life Sciences or Engineering
Preferred
MS in Life Sciences or Engineering and 4+ years of applicable experience
PhD in Life Sciences or Engineering and without any experience years of applicable experience
Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
Experience with startup projects or initiatives
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
Company
FUJIFILM Diosynth Biotechnologies
Fujifilm Diosynth Biotechn, contract development & manufacturing provider for preclinical, clinical and commercial biologics manufacturing.
1,001-5,000 employees
H1B Sponsorship
FUJIFILM Diosynth Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Morten Munk
Director - Global Alliance Management
S
Sharyn Farnsworth
Associate Principal Scientist
Recent News
Wake County Government (.gov)
2024-05-24
Company data provided by crunchbase
