Qualification Specialist in Equipment Integration (GMP/Lab Systems) - Forest Hills, NY (Onsite)

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 6 Month(s)
100% Travel

Skills

Stakeholder Management
Laboratory Equipment
Continuous Improvement
Data Integrity
Data Migration
GMP
Management
Communication
Computer Hardware
Documentation
Collaboration
Migration
Network
Operating Systems
Risk Management
System Integration
Risk Assessment
Regulatory Compliance
Release Management
Change Control

Job Details

Hi ,

The following requirement is open with our client.

Title : Qualification Specialist in Equipment Integration (GMP/Lab Systems)

Location : Forest Hills, NY (Onsite)

Duration : 6 Months

Visa Status : H1B/Transfer/OPT EAD/ EAD

Relevant Experience (in Yrs): 6-8

Detailed Job Description:

As a Qualification Specialist in the Equipment Integration Team, you will ensure compliance with GMP requirements for the migration of laboratory equipment from the Spark Network to the Roche Connect Network (RCN). This includes replacing hardware and operating systems, renewing applications, and managing configuration and data migration.

Job Responsibilities:

  • Qualification Strategy: Develop and implement qualification strategies for digital lab equipment, ensuring compliance with GMP, data integrity, and Roche internal standards.
  • Qualification Planning & Execution: Create qualification plans, protocols, and test documentation for equipment connected to RCN. Ensure execution aligns with procedures and regulatory requirements.
  • Risk Assessment: Perform risk assessments for digital solutions, identifying potential GMP and data integrity risks, and implement mitigation strategies.
  • Testing & Validation: Collaborate with cross-functional teams and QA SMEs to perform testing, qualification, and verification of lab systems and digital solutions.
  • Compliance & Documentation: Ensure complete traceability of qualification activities, maintaining accurate and compliant documentation (plans, protocols, reports, change controls).
  • Continuous Improvement: Drive improvement of qualification processes, tools, and methodologies; remain current with evolving GMP validation trends and regulatory updates.
  • Stakeholder Management: Act as the liaison between IT, QA, and business teams, leading scoping sessions and driving initiatives related to lab system integration and release management.

Must-Have Skills:

  • Strong experience in GMP environments and lab systems qualification.
  • In-depth understanding of equipment lifecycle models, risk management, and validation principles.
  • Experience in qualification of digital solutions and release management processes.
  • Proven ability to manage documentation, change control, and compliance activities.
  • Excellent communication, stakeholder management, and collaboration skills.

Thanks and Regards,

Goutham Eluri

Technical Recruiter

ASCII Group LLC.

38345 W. 10 Mile Rd, Ste.#365; Farmington, MI 48335

Office:

Email: Website:

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.