Quality Assurance Compliance Specialist

LanceSoft Inc; Rockaway (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading consultancy firm is seeking a Lead Quality Assurance resource to provide quality support for global computer validation projects in ERP such as SAP. The ideal candidate will have a Bachelor's degree in Engineering or Sciences and 5-8 years of experience in the life sciences industry focusing on Quality Assurance. Responsibilities include reviewing validation strategies, ensuring compliance, and participating in audits. Candidates should possess strong interpersonal and organizational skills, along with knowledge of GxP systems.

Qualifications

• Minimum of 5-8 years experience in the life sciences industry focusing on Quality Assurance.
• In-depth knowledge of US FDA regulations, ISO standards, and ICH guidelines.
• Extensive experience in risk-based approaches for computer systems validation.

Responsibilities

• Review and provide input to validation and test strategies.
• Verify documentation compliance with procedures and regulations.
• Participate in audits and change management processes.

Skills

Experience with GxP Enterprise Computerized Systems

Knowledge in SAP

Microsoft Office experience

Good organization skills

Strong interpersonal skills

Education

Bachelor's Degree in Engineering or Sciences

Tools

Microsoft SharePoint

Job description

Lead Quality Assurance resource needed to provide quality support for global computer validation projects in the ERP area, such as SAP, under the guidance of the Global Quality Computer Compliance team.

Job duties will include:

• Reviewing and providing input to validation and test strategies
• Verify documentation is in compliance with internal procedures and external regulations
• Participate in review and approval of requirements, test scripts, reports and other SDLC documentation with a focus on quality, and testability
• In addition, the resource may be pulled to support other programs of the following as needed:
• Participate in process changes in the organization
• Participate in audits
• Participate in change management of additional systems

Education/Training/Work Experience:

The position requires a Bachelor’s Degree in Engineering or Sciences with a 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. Candidate 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.

Specialized Knowledge and Skills: Knowledge in SAP is a plus. In addition, 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.