Apply on Employer Site

FUJIFILM Cellular Dynamics, Inc · 9 hours ago

QA Specialist, PQS

US-NC-Holly Springs

Full-time

Onsite

Entry Level

2+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina, and is seeking a QA Specialist, PQS to manage quality assurance activities within the Pharmaceutical Quality Systems team. The role involves collaborating with site-based customers and global colleagues, providing oversight of quality processes, and ensuring compliance with governing procedures in a cGMP regulated environment.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Supports QA for project deliverables in accordance with the governing processes, and procedures within the assigned Quality area

Assesses the impact of system controls and process modifications and maintains oversight of change management processes

Provides Quality/GMP oversight and approval of assigned area/systems and processes lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports

Reviews and approves QA procedures for the validation approach and lifecycle documents as assigned

Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of assigned area/systems in cGMP regulated facility

Ensures project and operational quality objectives are met within desired timelines

Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency

Supports quality decisions that may impact operations, ensuring appropriate escalation

Identifies risks and communicates gaps for quality and GMP process/systems

Performs other duties, as assigned

Qualification

GMP environment experienceQuality oversightRisk assessmentsValidation protocolsLife Sciences degreeCollaboration skillsProblem solvingCommunication skills

Required

BS/BA in Life Sciences or Engineering or equivalent with 2+ years of applicable industry experience OR

Masters in Life Sciences or Engineering with 0 years of applicable industry experience

1-3 years of experience in a GMP environment

Preferred

Prior experience working within a QA role preferred

Company

FUJIFILM Cellular Dynamics, Inc

Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.

Founded in 2004

Madison, Wisconsin, USA

51-200 employees

https://www.fujifilmcdi.com

H1B Sponsorship

FUJIFILM Cellular Dynamics, Inc 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

Represents job field similar to this job

Trends of Total Sponsorships

2023 (4)

2021 (1)

2020 (3)