Manager, Quality Assurance - NJ in Madison, NJ at Apex Life Sciences

Date Posted: 9/27/2018

Job Snapshot

Job Description


Job Description:

  • Lead Quality Assurance resource needed to provide 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.
  • Job duties will include:
    • reviewing and providing input to validation and test strategies;
    • verify documentation is in compliance with internal procedures and external regulations;
    • communicate quality requirements across various departments,
    • 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 Sciences or Engineering 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 TrackWise and Crystal Reports 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. 

Demands:

  • Sitting, light lifting, standing, and operating a PC.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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