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Quality Assurance Senior Specialist
West Greenwich, RIDescription:
**This is a Hyrbid 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"
**This is a Hyrbid 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"