Overview
Quality Assurance Senior Specialist Jobs in West Greenwich, Rhode Island, USA at Advanced Bio-Logic Solutions Corp
Location: West Greenwich
Description:
This is a Hybrid position in West Greenwich, RI location. Local candidates only. EW will report onsite at least 1-2 days a week and 3 days can be remote.
Basic Qualifications
Doctorate degree and 2 years of experience or Master degree and 6 years of experience or Bachelor degree and 8 years of experience or Associate degree and 10 years of experience or high school diploma / GED and 12 years of experience.
Top 3 Must Have Skill Sets:
Demonstrated abilities in problem solving, and experience managing deviation/change control/ CAPA.
Experience in Qualification/Validation including process, equipment and computer validation.
Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance.
Day to Day Responsibilities:
Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.
Develop and maintain a working understanding of applicable requirements and best practices.
Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control.
Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols.
Review/approve validation documentation, protocols, reports supporting the following qualification/validation disciplines:
Equipment, Computer, Process.
Review/approve equipment and computerized systems periodic review reports, as well as environmental qualification protocol reports.
Manage the change control process, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow processes and procedures.
Collaborate with project teams to integrate quality considerations and controls into project planning and execution.
Independently assess and prioritize quality risks across various functions and processes.
Implement proactive measures to prevent potential issues and ensure a state of inspection readiness.
Drive continuous improvement initiatives at the site and network level to create value for the business.
Pay Rate between $35 – $40/Hr on W2 based on experience.
This posting is for Contingent Worker, not an FTE.
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Title: Quality Assurance Senior Specialist
Company: Advanced Bio-Logic Solutions Corp
Location: West Greenwich, Rhode Island, USA
Category: Quality Assurance – QA/QC
