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SSi People · 3 days ago
Quality Assurance Specialist
Summit, NJ
Contract
Onsite
Entry Level
1+ years exp
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Hiring Manager
Shashikant Binjalabhavi
Insider Connection @SSi People
Responsibilities
Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
Lead investigations and cross functional investigation teams, and close reports in a timely manner
Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis.
Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
May Initiate change control documentation
Identify functional area SMEs to perform impact assessments as part of the change management process.
Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
Support deviation investigation defense during audits and site inspections related inquiries.
Qualification
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Required
Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline
Minimum 1 year of relevant work experience, preferably in a health authority regulated environment
Preferred
Advanced degree
Previous experience working in a biopharmaceutical manufacturing facility (CAR T a plus)
Company
SSi People
Founded in 1998 and located in Cranberry Twp., PA.
51-200 employees
H1B Sponsorship
SSi People 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
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Ron Seibert
President and CEO
Company data provided by crunchbase
