Quality Assurance Manager
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The Opportunity Description We're looking for a Quality Assurance Manager, working in Pharmaceuticals and Medical Products industry in 5 Giralda Farms, Madison, New Jersey, United States.
Job Description:
Provides independent quality support for global computer validation projects in the quality/regulatory area, such as TrackWise, under the guidance of the Global Quality Computer Compliance team.
Reviews and provides input to validation and test strategies; verifies documentation in compliance with internal procedures and external regulations; communicates quality requirements across various departments, participates in review and approves requirements, test scripts, reports and other SDLC documentation with a focus on quality, and testability.
Participates in process changes in the organization.
Participates in audits.
Participates in change management of additional systems.
Our Client Our client is an award-winning clinical development company.
Improving lives globally with 20
years experience in clinical research and strategic resourcing.
Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities.
Industry expertise sets you up for success with helpful insights, career coaching, and professional training.
Grow and learn while you put your skills to work.
Experience Required for Your Success Requirements:
Bachelors Degree in Engineering or Sciences Minimum of 5-8 years experience working in life sciences industry with focus in the area of Quality Assurance Experience working with various GxP Enterprise Computerized Systems (on-premise and Cloud based (SaaS) COTS) used in the life sciences industry Must be well-versed with Software Development Life Cycle (SDLC) methodologies such as Waterfall and V-model In-depth knowledge of US FDA regulations, ISO standards, MHRA and EU regulations (including Annex 11), and ICH guidelines and Drug Development Life Cycle process Extensive experience developing and using risk based approaches for computer systems validation Experience in managing multiple projects and determined to get job done correctly and on time Knowledge in TrackWise and Crystal Reports is a plus Microsoft Office experience (Word, Excel, PowerPoint) Experience with Microsoft SharePoint is also recommended Good organization skills and strong interpersonal skills as well as ability to work with other departments What Do You Think? Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Recommended Skills Auditing Biotechnology Change Management Clinical Research Coordinating Crystal Reports (Reporting Software) Estimated Salary: $20 to $28 per hour based on qualifications.
The Opportunity Description We're looking for a Quality Assurance Manager, working in Pharmaceuticals and Medical Products industry in 5 Giralda Farms, Madison, New Jersey, United States.
Job Description:
Provides independent quality support for global computer validation projects in the quality/regulatory area, such as TrackWise, under the guidance of the Global Quality Computer Compliance team.
Reviews and provides input to validation and test strategies; verifies documentation in compliance with internal procedures and external regulations; communicates quality requirements across various departments, participates in review and approves requirements, test scripts, reports and other SDLC documentation with a focus on quality, and testability.
Participates in process changes in the organization.
Participates in audits.
Participates in change management of additional systems.
Our Client Our client is an award-winning clinical development company.
Improving lives globally with 20
years experience in clinical research and strategic resourcing.
Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities.
Industry expertise sets you up for success with helpful insights, career coaching, and professional training.
Grow and learn while you put your skills to work.
Experience Required for Your Success Requirements:
Bachelors Degree in Engineering or Sciences Minimum of 5-8 years experience working in life sciences industry with focus in the area of Quality Assurance Experience working with various GxP Enterprise Computerized Systems (on-premise and Cloud based (SaaS) COTS) used in the life sciences industry Must be well-versed with Software Development Life Cycle (SDLC) methodologies such as Waterfall and V-model In-depth knowledge of US FDA regulations, ISO standards, MHRA and EU regulations (including Annex 11), and ICH guidelines and Drug Development Life Cycle process Extensive experience developing and using risk based approaches for computer systems validation Experience in managing multiple projects and determined to get job done correctly and on time Knowledge in TrackWise and Crystal Reports is a plus Microsoft Office experience (Word, Excel, PowerPoint) Experience with Microsoft SharePoint is also recommended Good organization skills and strong interpersonal skills as well as ability to work with other departments What Do You Think? Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Recommended Skills Auditing Biotechnology Change Management Clinical Research Coordinating Crystal Reports (Reporting Software) Estimated Salary: $20 to $28 per hour based on qualifications.
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