SQA Tester/Technical Documentation Writer (11427730) through Kelly Services, Rochester NY

Job Code : BHJOB3479_442391
Job Type : Full Time
Category : IT/Software Development
Career Level : Experienced (Non-Manager)
Education : Associate Degree
Compensation : 0.00 Per Year
Location : Rochester NY US 14609

For over 60 years, Kelly Services has provided outstanding employment opportunities, including temporary, direct hire, and temporary-to-hire, to the most talented individuals in the marketplace.

Our client, a well known company in the Rochester, NY area has an immediate need for an experienced SQA Test Analyst/Technical Documentation Writer. This is a 1-year-plus contract assignment for the right candidate with potential for contract to hire.

Job Description:

Experienced SQA Test Analyst and Technical Documentation Writer to develop/create and review project tests and validations throughout the software development lifecycle (SDLC).

Specific Job Duties:

  • Test and validate software to meet business requirements
  • Support project activities related to testing enhancements to the shop floor & SCADA systems
  • Coordinates activities between and with Plant SQA and Plant IT
  • Review and enhance Plant SOP’s as needed via electronic Document Control process
  • Will utilize the SDLC Templates for Software Validation including: Change, Planning, Requirements, Testing, Configuration and Risk Management
  • CFR21 Part 11 compliance
  • Develop detailed test cases/scripts from user and/or functional requirements for software systems (SFIS, PLC, and database) execute them with due diligence
  • Develop test cases that exercise new features under development
  • Ensure compliance to company and regulatory requirements including CFR Part 11.
  • Enter problems and solutions using company discrepancy Reporting and Change Control processes
  • Work closely with Development, Product Management and Technical teams to help with timely investigation and response to reported defects and problems
  • Support the development & implementation strategies for the management of the Software Development Lifecycle through collaboration with Quality, IT, and Controls Engineering



  • Technical writing and documentation in structured template formats
  • Oracle / SQL database experience
  • Validation documentation and testing experience
  • Must be willing to change priorities to meet changing business needs
  • Documentation experience in an FDA controlled environment
  • Electronic systems for document control, quality change requests, training and compliances


  • Associates/Bachelors degree in Information Systems, Computer Science, Computer Engineering or Information Technology with a minimum 4-6 years of relevant work experience desired.
  • Minimum of two years experience testing real-time, embedded software systems

Preferred Skills/Experience:

  • Experience in developing test cases covering boundary verification, conformance to requirements, fault handling and stress testing and debugging
  • Experience in a GMP/Quality System Regulated industry
  • The ability to understand and work to complex technical specifications
  • Good knowledge of manufacturing systems
  • The ability to analyze problems and offering solutions
  • The ability to quickly integrate and make a significant contribution to the company
  • Technically advanced in understanding networks, OS Platforms, remote applications
  • Strong communication skills. Able to work closely with staff to understand and communicate technical issues
  • Good team player but able to work on own initiative

Key Skills:

  • SW SDLC & SQA Testing
  • Full Cycle Test Project experience – Begin to end
  • Process Verification
  • Requirements Analysis
  • Validation Testing
  • IQ/OQ/PQ
  • Testing Methodology
  • Change Control / Change Management
  • Document Control / Document Management
  • FDA CFR 21 Parts 11, 820, 860
  • GMP
  • TOAD, NetOps
  • SQL / Oracle
  • Kintana
  • Documentum
  • Sharepoint
  • Electronic Signatures & Documentation

Kelly IT Resources® is a specialized business unit of Kelly Services®, focused on the placement of professionals in contract, contract-to-hire and full-time employment positions across all IT disciplines. By matching the staffing needs of technical organizations with highly qualified information technology professionals, we place nearly 8,000 IT professionals on assignment each year. Kelly Services is an Equal Opportunity Employer.

To apply: