Business System Support Specialist

4 days ago

Middleton, Massachusetts, United States Mindlance Full time
Job Summary:

As a Business System Support Specialist at Mindlance, you will play a crucial role in providing basic business/system support of software systems and/or laboratory instrumentation. Your responsibilities will include working with staff of various departments and the client to initiate and complete performance qualification (PQ) validation. You will facilitate the validation process and implementation of system upgrades, including guiding, testing, and supporting the introduction and ongoing support of software systems.

Key Responsibilities:

  • Participate as a validation representative at project team meetings and complete assigned action items. Provide direction for future releases to software systems; review and approve/reject change requests. Communicate proactively with all project team members and provide regular feedback to management concerning timeline/budget or resource constraints.
  • Provide validation support for new releases and modifications to applications throughout the software development life cycle. Prepare validation plans, test cases, and validation summary reports, and execute test cases.
  • Review and approve all change controls associated with validated systems per SOP. Review PQ and change control documentation with leadership per SOP.
  • Ensure test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.
  • Execute test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably, proving the software functions correctly. Create, update, and manage sufficient data within the testing environment to accurately test software functionality. Work with leadership to address any PQ-related issues arising from client or internal audits.
  • Manage assignments to meet deadlines and produce high-quality deliverables. Remain familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs.
  • Participate in the identification of user requirements and system design and assist in the preparation and review of system documentation such as requirements and design specifications for software systems and/or instrumentation.

Requirements:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
  • In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

Preferred Qualifications:

  • Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others
  • Strong attention to details and problem-solving skills
  • Demonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum instruction
  • Positive attitude, enthusiasm toward work, and the ability to work well with others
  • Effective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines
  • Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC)
  • Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced
  • Ability to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process maps
  • Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans. Ability to assess the cause of test failures
  • Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team

What We Offer:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

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