W-2 Jobs Portal

  • W-2 Open Positions Need to be Filled Immediately. Consultant must be on our company payroll, Corp-to-Corp (C2C) is not allowed.
Candidates encouraged to apply directly using this portal. We do not accept resumes from other company/ third-party recruiters

Job Overview

  • Job ID:

    J36993

  • Specialized Area:

    Business Analyst

  • Job Title:

    Business Analyst

  • Location:

    St. Louis,MO

  • Duration:

    16 Months

  • Domain Exposure:

    Banking & Finance, Education, IT/Software

  • Work Authorization:

    US Citizen, Green Card, OPT-EAD, CPT, H-1B,
    H4-EAD, L2-EAD, GC-EAD

  • Client:

    To Be Discussed Later

  • Employment Type:

    W-2 (Consultant must be on our company payroll. C2C is not allowed)




Job Description

Responsibilities:

  • Performing, reviewing and/or approving quality and compliance work activities and documentation related to IT change management, computer system validation, periodic activities and software development.
  • Assist in integrating the IT department with both site manufacturing quality and global IT quality processes procedures as well as assist in continuous improvement projects for IT quality and compliance operations.
  • Manage projects and compliance activities as assigned.
  • Perform BT Quality Management activities related to qualification, GXP validation, and change-management of IT systems.
  • Provide technical expertise to write computer system lifecycle, validation, and decommissioning documentation in accordance with cGxP, 21 CFR Part 11, 210, and 211, and other applicable regulations and procedures.
  • Develop and manage project documentation for SDLC requirements during computer system implementation projects including developing user and functional requirements; technical and functional business process flows, use case, test case and test script documents; perform functionality, usability and testing during required project phases.
  • Perform IT system periodic activities and oversee the process for completion according to quality procedures.
  • Assist in performing impact assessments and work with technical SMEs to close-out IT related CAPAs and commitment tracking items.
  • Represent company BT in site level change control meetings and act as main point of contact for company BT core solution teams regarding change management, quality assurance and compliance management.
  • Work with Site Quality Organization and company BT Quality Assurance personnel staff to review, update and approve all documentation.
  • Act in a project lead and/or business analyst capacity for assigned projects to include performing project documentation, tracking and communicating project status and status of deliverables, risk and issue analysis and problem resolution.
Business Analyst
 

Job Requirements

Qualifications:

  • Bachelor's degree in Computer Science, Information Technology or other science-related discipline.
  • BA with CSV (computer systems validation) experience.
  • At least 1 year of experience (ideally 3+ years) in current Good Manufacturing or Laboratory Practices, CFR 21 Part 11 regulations, Good Documentation Practices, and other applicable regulations for validated computerized systems.
  • At least 1 year of experience (ideally 3+ years) in writing Validation Documents (e.g. Validation Master Plans, Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).
  • Must have demonstrated capability in completing projects according to prescribed timelines and other requirements in previous project management or business analyst roles.
  • Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.
  • Be able to function in multidisciplinary teams, must possess excellent documentation, presentation, training and computer skills.
  • Experience w/ Aseptic Techniques, Manufacturing, GMP and FDA.

  • Experience with SDLC and other IT project management methodologies; Agile development is a plus.
  • Lean Six Sigma certification and/or experience preferred.
  • Familiarity with lab systems, plant manufacturing systems, Document Management Systems, CAPA processes, Learning Management Systems, highly desirable.

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Equal Opportunity Employer

DIGITAL TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. DIGITAL TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will DIGITAL TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract