Validation Analyst

Compensation

: $70,890.00 - $120,340.00 /year *

Employment Type

: Full-Time

Industry

: Pharmaceutical/Biotechnology



Loading some great jobs for you...





Title: Validation Analyst
Location: Wilson, NC 27893, USA
Duration: 9 Months
Shift: M-F (8 am-5 pm)


Qualifications:
4+ years of Lab Systems validation experience is required
Mettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters; 2+ years experience with LabX method development and validation preferred.
Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
Understanding of Data Integrity concepts is required
Excellent communication and written skills required Education- Bachelors required '

Responsibilities:
Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems & LabX (Mettler)
Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
Coordinate alignment of systems users from various company groups on validation and qualification documentation
Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc. ' Skill Requirements.



Job Requirements:
  • Responsibilities:
    Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems & LabX (Mettler)
    Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
    Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
    Coordinate alignment of systems users from various company groups on validation and qualification documentation
    Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
    Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
    Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc. ' Skill Requirements.

Associated topics: ascp, blood collection, hematopathology, lab, laboratory, sample collection, services, surgical technologist, technician, technician i * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

Launch your career - Create your profile now!

Create your Profile

Loading some great jobs for you...