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IT Business Systems Support Analyst, Technical CSV + Systems Support

Position Summary:

This across the IT Business Systems Team with a primary focus on IT computer system validation activities and processes. As a centralized IT point of contact for computer system validation activities and artifacts, this individual will provide oversight and continuity for detailed system process controls across the Apellis technology portfolio for validated software solutions.

This individual will be responsible for:

  • promotion of an iterative, incremental system enhancement and maintenance methodology to optimize and Apellis configuration/enhancement release schedule with each vendor's technology release schedule
  • provide oversight and continuity of the computer system validation processes and technology best practices for risk-based impact assessments, testing, system deployment controls, and documentation.
  • IT liaison between Quality Validation for operational processes to continuously improve and process system releases and system changes

Additional system responsibilities may include (variable by system and vendor support models):

  • system support management, including coordination of application configuration and support performed by service and support vendor(s)
  • end user support, system administration
  • workflow scenario (positive and negative) testing, including technical and end user testing

This individual will report to the IT Business Systems Manager and will work across the IT Business Systems Team.

Key Responsibilities:

  • Ensures consistent, standard, IT best practices are applied to Computer System Validation processes and artifacts including: Assessments, Plans, Requirements/Specifications, Scripts and Reports:
    • Distinguishes between technology solutions (i.e. private or client-server solutions vs multi-tenant cloud based solutions) and validation services (i.e. technology platform vs client configurations)
    • Ensures supporting artifacts to computer system validation and change control documentation is consistently provided across validated systems and teams
    • Facilitates and/or participates in change/release impact assessments and periodic system assessments (on-going maintenance and controls).
  • Promote and identify continuous improvements across IT, Quality Validation, and Business System Owners/Teams to enable Apellis' IT technology methodology of an iterative, incremental system enhancement and maintenance process

Additional System Support Responsibilities:

  • Coordinates support activities across internal and external personal, including managed services and support vendor(s).
  • Identify and troubleshoot procedural, operational and configuration issues.
  • Provide IT system support, including vendor operational and maintenance and oversight to the vendor's SLAs.

Skills, Knowledge & Abilities:

  • Self-motivated and passionate to learn and adopt new technology and methodologies
  • Team-oriented and generous in sharing knowledge and enabling others
  • Reliable, consistent, and proactive
  • Capable of day-to-day problem solving and taking responsibility for decisions
  • Customer Service oriented with attention to detail and quality
  • Must be able to effectively prioritize and plan. Ability to address multiple projects and adapt to changing priorities.
  • Strong verbal and written communication skills
  • Ability to communicate and work independently with cross-functional/inter-departmental teams and within the framework of the IT organization.
  • Strong understanding and working knowledge of FDA 21 CFR Part 11, ICH E6
  • Proficient in Microsoft Word, Excel, PowerPoint and other applications.

Experience:

  • Experience with client-(web)server technologies and multi-tenant cloud based technologies is required.
  • Experience in working with software vendors for support and maintenance
  • Experience with GxP guidelines, Computer Software Validation (CSV), and IT SDLC
  • Experience working in a GxP environment(s) (FDA, EU, MHRA) is required.
  • Strong understanding and working knowledge of FDA 21 CFR Part 11, ICH E6
  • Bachelor's degree in computer science, technology, operations, or related disciplines required.
  • 5+ years in a pharmaceutical/biotech or related environment required position, IT Business Systems Support Analyst, will support several systems and functional areas

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more! Visit https://apellis.com/careers/ to learn more.

Company Background:

At Apellis, we are committed to developing transformative therapies for people living with a broad range of debilitating diseases by controlling complement, part of the body's immune system. Our work is rooted centrally at C3, which is the only target in the complement cascade that addresses all three pathways that can drive disease. Targeting C3 has broad platform potential to treat many diseases where patients have few or no treatment options available. Our programs across ophthalmology, nephrology, hematology, and neurology are further exploring what is possible by targeting C3.

Visit https://apellis.com/about-us/ut.html to learn more.

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Posted
07/09/2022
Location
Waltham, MA, 02451, US