Job ID : 33196
Location : West Windsor, NJ
Company Name : Merit Technology Services
Job Type : Full-Time, contract
Industry : Healthcare
Salary : $35000 - $60000 per year
No. of Positions : 10+
Required Skills : SDLC, IQ/OQ protocols, test scripts, FDA, cGMP.
Benefits : Medical Insurance
0-2 years or Freshers can apply
· Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
· Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
· Perform testing of the entire SDLC, including version/change control and new software rollouts.
· Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.
· Author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utilities equipment.
· Assist in the design and procurement of new process and utility equipment and lead installation, start-up and commissioning or qualification activities.
· Author IQ/OQ protocols for new or used equipment purchased.
· Review IQ/OQ protocols provided by equipment manufacturers to ensure compliance with site procedures.
· Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
· Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).
· BS in Engineering, Science, or equivalent technical degree.
· 0-2 years experience required
· Excellent written and verbal communication skills; excellent technical writing skills.
· Strong interpersonal skills and the ability to work in a team environment.
· Ability to work effectively in a fast-paced multitasking environment.
· Strong working knowledge of FDA and cGMP regulations and documentation practices.
· Proficient in Microsoft Word, Excel, PowerPoint.
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