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QA IT Specialist Consultant

  • Consultants
  • Worker Status: Contingent Worker
  • Time Type: Full time
    • US - Remote

Description

General Scope and Summary

SAGE Therapeutics is searching for a highly motivated, detail-oriented individual with excellent communication skills (both written and verbal) to join our QA IT Team as a QA IT Specialist Consultant. This role will support QA oversight of Data Integrity and Computer System Validation activities for GxP Computerized Systems.

Roles and Responsibilities (Essential Functions)

  • Supports and monitors the Data Integrity Program including managing the timeline of activities for data integrity deliverables (e.g., data integrity assessments, CAPA actions, interim controls, remediations, etc.).
  • Conducts data integrity assessments to ensure compliance with regulatory requirements.
  • Supports the development and review of data process maps.
  • Participates in audit trail risk assessments and audit trail reviews.
  • Supports the implementation and maintenance of data integrity controls.
  • Delivers training on data integrity to foster awareness and accountability.
  • Provides support for QA Oversight of Computer Systems Validation (CSV) activities related to initial implementation, changes, maintenance and decommissioning of GxP systems.
  • Supports the review of quality event records (e.g., IT Change Control, Deviation, CAPAs, etc.) for GxP systems.
  • Reviews and approves CSV deliverables ensuring adherence to regulatory requirements and Sage policies and procedures.
  • Actively participates in the release impact assessment process and approval of SaaS releases.
  • Supports the periodic review process of validated GxP computerized systems. Reviews, analyzes and identifies compliance gaps incurred throughout the lifecycle of GxP systems.
  • Supports the development and revision of QA IT and CSV procedures and validation templates.
  • Collaborates across functions and within Quality to identify areas of improvement.
  • Evaluates project timelines to correctly ascertain proper time/resource estimates.

Experience, Education and Specialized Knowledge and Skills

Suitable candidates must thrive and excel in an environment that embraces “putting people first,” teamwork, change, risk-based decision making, and flexibility. Successful candidates must be self-motivated to take action, possess strong attention to detail, be open to sharing ideas, and be comfortable with healthy/productive conflict and conflict resolution.

Basic Qualifications

  • A minimum of five (5) years of demonstrative, practical experience in Quality Assurance overseeing CSV of GxP computerized systems.
  • Strong understanding and hands-on experience in implementing and maintaining data integrity principles and controls.
  • Strong understanding of 21 CFR Part 11, EU Annex 11 regulations and GAMP 5 concepts, applications, and best practices.
  • Strong working knowledge of computer system validation, computer software assurance, GAMP-based risk assessment and risk management approach.
  • Possesses strong written and verbal communication skills.

Preferred Qualifications

  • Demonstrated ability to apply risk-based approaches to information system selection, testing, implementation, and maintenance.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team.
  • Understanding of configuration management, software development and CSV lifecycle, Agile/Scrum and Waterfall development approaches.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.

Job ID: R002159

#Biotechnology #Careers #ThisIsSage

EEO IS THE LAW

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

EEO is the Law

EEO is the Law - Supplement

Pay Transparency Nondiscrimination

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.

Employment applications

Employment applications are processed through a website that is not owned or controlled by Sage Therapeutics, Inc. Sage Therapeutics, Inc. makes no representation as to the accuracy of the information contained on websites it does not own or control. Sage Therapeutics, Inc. does not recommend and does not endorse the content of any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

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