Confidential
Senior Quality Assurance Specialist
Confidential, Waltham, Massachusetts, United States, 02254
Job Title
Quality Assurance Senior Specialist Location
Waltham, Massachusetts 02451 Work
The R&D Quality Assurance Senior Specialist will work closely with the R&D functions in the execution of clinical trials and serve as the Quality Assurance representative for assigned studies. The role will be a quality subject matter expert and champion for high standards of regulatory compliance. Key Responsibilities
Review clinical study documents for consistency, compliance with procedures, regulations, standards and best practices. Serve as a quality SME and provide guidance to R&D personnel performing investigations, root cause analysis and CAPAs; act as Quality approver for deviations and CAPA related to assigned studies. Participate in cross-functional teams as SME in GCP to provide guidance and risk-based options that promote compliance. Function as Quality contact for audits of vendors and investigator sites and other study specific audits (e.g., CSR and TMF). Identify quality process and system improvements and implement timely actions. Identify and communicate quality and compliance risks and participate in determination of appropriate planning to resolve and address issues and risks. Support the GCP inspection readiness (IR) strategy by leading IR activities for assigned studies and participating in regulatory inspections. Coordinate projects to successfully meet timelines. Other duties as assigned. Education
BA/BS, preferably in a Life Science discipline Qualifications
Minimum 5 years of direct GCP Quality Assurance experience in regulated industry (pharma/biotech/CRO and medical device). Thorough knowledge of FDA and ICH Good Clinical Practices (GCP) requirements and regulations. Experience in supporting Regulatory Authority GCP inspections. Experience managing internal and contract personnel and external vendors and auditors. Ability to communicate effectively and non-confrontationally with internal departments. Proven ability to work in a fast-paced environment, handling multiple demands and shifting priorities with flexibility and willingness. Seniority Level
Associate Employment Type
Contract Job Function
Manufacturing and Quality Assurance Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Quality Assurance Senior Specialist Location
Waltham, Massachusetts 02451 Work
The R&D Quality Assurance Senior Specialist will work closely with the R&D functions in the execution of clinical trials and serve as the Quality Assurance representative for assigned studies. The role will be a quality subject matter expert and champion for high standards of regulatory compliance. Key Responsibilities
Review clinical study documents for consistency, compliance with procedures, regulations, standards and best practices. Serve as a quality SME and provide guidance to R&D personnel performing investigations, root cause analysis and CAPAs; act as Quality approver for deviations and CAPA related to assigned studies. Participate in cross-functional teams as SME in GCP to provide guidance and risk-based options that promote compliance. Function as Quality contact for audits of vendors and investigator sites and other study specific audits (e.g., CSR and TMF). Identify quality process and system improvements and implement timely actions. Identify and communicate quality and compliance risks and participate in determination of appropriate planning to resolve and address issues and risks. Support the GCP inspection readiness (IR) strategy by leading IR activities for assigned studies and participating in regulatory inspections. Coordinate projects to successfully meet timelines. Other duties as assigned. Education
BA/BS, preferably in a Life Science discipline Qualifications
Minimum 5 years of direct GCP Quality Assurance experience in regulated industry (pharma/biotech/CRO and medical device). Thorough knowledge of FDA and ICH Good Clinical Practices (GCP) requirements and regulations. Experience in supporting Regulatory Authority GCP inspections. Experience managing internal and contract personnel and external vendors and auditors. Ability to communicate effectively and non-confrontationally with internal departments. Proven ability to work in a fast-paced environment, handling multiple demands and shifting priorities with flexibility and willingness. Seniority Level
Associate Employment Type
Contract Job Function
Manufacturing and Quality Assurance Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr