Hamilton
As a Senior Quality Assurance Specialist, you will support a multi-discipline team whose areas of responsibilities include: Leading investigations, CAPA management, Lean/Six Sigma program, project management within manufacturing and SAP, use of the SAP template with specific focus on the Production Execution (PEX) module of SAP.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by the state or local law and where vaccine supply is readily available. GSK employees working in Montana are excluded from the Company mandate per House Bill 70
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Execute all activities following quality and regulatory standards and procedures. Promote a quality mindset and quality excellence approach to all activities.
Support continuous improvement culture, industrial excellence methodologies, lean metrics, and key KPI’s.
Will be responsible for performing technical review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
Will be responsible for approving batch records, summary reports and other release documentation as necessary.
Will be responsible for one of the following major quality systems: Change Control, CAPAs, QA holds, Material Rejection Reports, Deviations, QMS, Technical Complaints/Adverse Events, L3/L4 RIMP, QA reporting and approval of GMP documentation.
Will be responsible for performance, review and approval for investigations associated with Complaints, Deviations, CAPA, OOS, Out of Tolerance, Atypical Results, Environmental Discrepancy Reports and Alert Level Reports.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's Degree in any Discipline
5+ years in cGMP pharmaceutical environment or industry focused on quality operations
As a Senior Quality Assurance Specialist, you will support a multi-discipline team whose areas of responsibilities include: Leading investigations, CAPA management, Lean/Six Sigma program, project management within manufacturing and SAP, use of the SAP template with specific focus on the Production Execution (PEX) module of SAP.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by the state or local law and where vaccine supply is readily available. GSK employees working in Montana are excluded from the Company mandate per House Bill 70
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Execute all activities following quality and regulatory standards and procedures. Promote a quality mindset and quality excellence approach to all activities.
Support continuous improvement culture, industrial excellence methodologies, lean metrics, and key KPI’s.
Will be responsible for performing technical review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
Will be responsible for approving batch records, summary reports and other release documentation as necessary.
Will be responsible for one of the following major quality systems: Change Control, CAPAs, QA holds, Material Rejection Reports, Deviations, QMS, Technical Complaints/Adverse Events, L3/L4 RIMP, QA reporting and approval of GMP documentation.
Will be responsible for performance, review and approval for investigations associated with Complaints, Deviations, CAPA, OOS, Out of Tolerance, Atypical Results, Environmental Discrepancy Reports and Alert Level Reports.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's Degree in any Discipline
5+ years in cGMP pharmaceutical environment or industry focused on quality operations
Hamilton
As a Senior Quality Assurance Specialist, you will support a multi-discipline team whose areas of responsibilities include: Leading investigations, CAPA management, Lean/Six Sigma program, project management within manufacturing and SAP, use of the SAP template with specific focus on the Production Execution (PEX) module of SAP.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by the state or local law and where vaccine supply is readily available. GSK employees working in Montana are excluded from the Company mandate per House Bill 70
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Execute all activities following quality and regulatory standards and procedures. Promote a quality mindset and quality excellence approach to all activities.
Support continuous improvement culture, industrial excellence methodologies, lean metrics, and key KPI’s.
Will be responsible for performing technical review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
Will be responsible for approving batch records, summary reports and other release documentation as necessary.
Will be responsible for one of the following major quality systems: Change Control, CAPAs, QA holds, Material Rejection Reports, Deviations, QMS, Technical Complaints/Adverse Events, L3/L4 RIMP, QA reporting and approval of GMP documentation.
Will be responsible for performance, review and approval for investigations associated with Complaints, Deviations, CAPA, OOS, Out of Tolerance, Atypical Results, Environmental Discrepancy Reports and Alert Level Reports.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's Degree in any Discipline
5+ years in cGMP pharmaceutical environment or industry focused on quality operations
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