FUJIFILM Cellular Dynamics, Inc · 1 day ago
Analyst, QA PQS
US-NC-Holly Springs
Full-time
Onsite
New Grad, Entry Level
0+ years expFUJIFILM Cellular Dynamics, Inc is building the future of bioproduction in Holly Springs, North Carolina. The QA Analyst, PQS assists in the quality oversight of PQS applications for the Enterprise Quality Systems administration and document control, collaborating with various teams and maintaining quality standards.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Supports QA for project deliverables in accordance with the governing processes and procedures within the assigned Quality area
Participates in assigned audits on a regular basis
Identifies, evaluates, and owns continuous improvement opportunities for the assigned quality area
Maintains quality oversight of quality systems owned by the assigned quality area
Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness and through cGMP operations
Uses discretion to make informed quality related decisions for the quality systems area
Actively supports quality decisions that may impact operations, ensuring appropriate escalation
Applies knowledge and skillset to be SME for support functionality such as Tableau
Monitors procedures, and reports and processes
Documents and communicates areas of concern, deviations, CAPA etc
Participates in risk assessments and assists in mitigating quality-related risks
Provides administrative support for quality systems, as required
Performs other duties, as assigned
Qualification
Required
Bachelor's Degree in Life Sciences (e.g., Engineering, Applied Science or Chemistry) with 0-1 years of experience
Basic experience or understanding of GMP, GLP, GDP requirements
Preferred
Prior experience in GMP environment
Previous quality systems experience
Company
FUJIFILM Cellular Dynamics, Inc
Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.
51-200 employees
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)
Funding
Current Stage
Growth StageLeadership Team
Blake Anson
Senior Director - Discovery Research Partnering
Ilyas Singec
Chief Scientific Officer
Recent News
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