32 applicantsPosted by Agency
Pyramid Consulting, Inc · 2 days ago
Associate Scientist
Summit, NJ
Contract
Onsite
Entry Level
$40/hr - $49/hr
1+ years exp
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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.
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.
Handle complex issues and solve problems with minimal guidance.
Serve as author or technical reviewer of departmental procedures as appropriate.
Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
Continuously support S12, living the “patients first” mission and fostering a “Right First Time” mindset.
The incumbent will be working 80% to 90% of the time in an office environment.
The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.
Qualification
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Required
Working experience of deviation investigations utilizing root cause analysis tools.
Working experience in the CAPA process and ability to identify and verify effectiveness.
Technical writing skills and ability to collaborate effectively in cross functional teams.
Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
Ability to support health authority inspections.
Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
Ability to set priorities, manage timelines and effectively react/manage changing priorities.
Ability to work with management (global and site) and support corporate and departmental goals.
Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system) or Infinity.
Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
Minimum 1 year of relevant work experience, preferably in a health authority regulated environment.
Preferred
Knowledge of data trending and tracking, including use of statistical analysis software a plus.
Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.
Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).
Benefits
Health Insurance
401(k) Plan
Paid Sick Leave
Company
Pyramid Consulting, Inc
Pyramid Consulting, a global leader in workforce and technology solutions, empowers individuals and organizations to transform and thrive in the most challenging and competitive markets.
5,001-10,000 employees
H1B Sponsorship
Pyramid Consulting, 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
Trends of Total Sponsorships
2023 (77)
2022 (60)
2021 (62)
2020 (93)
Funding
Current Stage
Late StageLeadership Team
Sanjeev Tirath
Founder & CEO
Recent News
Atlanta Business Chronicle
2023-11-09
Company data provided by crunchbase
