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Quality Systems Administrator (Biotech)

SkySource Solutions

Quality Systems Administrator (Biotech)

Waltham, MA
Full Time
Paid
  • Responsibilities

    Job Description

    We are seeking a Quality Systems Administrator (Biotech) __ to join our team! You will handle a variety of projects and must have hands on Veeva experience – they will essentially be IT support for the Veeva systems.

    RESPONSIBILITIES:

    • ​You will handle a variety of projects and must have hands on Veeva experience – they will essentially be IT support for the Veeva systems.

    • The GxP Systems Administrator is a knowledgeable individual that configures, supports, and maintains regulated information systems in accordance with our Policies, SOPs, and industry best practices. The GxP Systems Administrator will also collaborate with the other departments to identify requirements and implement systems in accordance with appropriate change controls in order to meet the requirements. The position supports compliance responsibilities including, but not limited internal system audits. The GxP System Administrator works with and supports GMP Manufacturing, Quality Control, Quality Assurance, Validation, among other teams across our BaseCamp.

    • System Administrator responsible for Veeva Vault and KNEAT Enterprise Cloud Systems, including User Administration and System Configuration.

    • Create and maintain SOPs and procedures related to GxP systems.

    • Follow Quality process to maintain systems in a validated state and ensure appropriate GxP systems are in compliance with 21 CFR part 11.

    • Collaborate with vendors, quality personnel, and IT colleagues to implement and support GxP systems in a controlled laboratory and manufacturing environment.

    • Assist with change control impact assessments for GxP systems change

    QUALIFICATIONS:

    • +3 years of hands-on Veeva Vault experience maintaining quality assurance of an IT environment.

    • Bachelor's Degree in Computer Science, Computer Information Systems (CIS), or related field

    • Understanding of GAMP 5, 21 CFR Part 11, Computer System Validation, and Change Control Working knowledge of Active Directory/LDAP and Windows Security.

     

    Company Description

    SkySource Solutions believes in attaining success. We know success is important to our clients, applicants, candidates, and our internal staff and want to be an integral part of that process. The SkySource Difference: We are not just another staffing firm! We truly care about our candidates long-term success and how we get there together. So the BIG Question is... How do we get there? Our team of Recruiters come with 5 plus years of industry experience and are not looking to just find you a job. We truly care about your short-term and long-term career goals and understand what's important in making that next career move. We want to understand what you are looking for from a cultural, compensation and benefits perspective. Apply today and experience the SkySource difference!