Data Integrity Consultant

• Perform Data Integrity assessments of laboratory equipment, instruments, computerized systems, and associated processes in accordance with approved assessment plans and procedures.
• Complete system inventory activities and document system functionality, configurations, data flows, user roles, and technical controls.
• Evaluate compliance with applicable Data Integrity regulations and guidance, including 21 CFR Part 11, Electronic Records and Electronic Signatures (ERES), ALCOA+ principles, and applicable cGMP requirements.
• Review user access management, audit trail functionality, system security, password controls, backup and recovery, data retention practices, and system time synchronization.
• Evaluate controls throughout the data lifecycle, including data creation, processing, review, reporting, storage, archival, and retrieval.
• Identify and document Data Integrity gaps, risks, vulnerabilities, and remediation opportunities, including assessment of potential validation impacts.
• Author Data Integrity Assessments and future-state Design and Configuration Specifications.
• Participate in laboratory walkthroughs, stakeholder interviews, peer reviews, comment resolution activities, and project meetings.
• Communicate project status, findings, risks, and recommendations to project leadership and client stakeholders.

This position is focused primarily on computerized laboratory systems supporting regulated laboratory operations. Candidates should possess hands-on experience with laboratory instrumentation, computerized systems, and Data Integrity compliance requirements within a GMP environment., * Bachelor’s degree in Life Sciences, Engineering, Computer Science, Biotechnology, Chemistry, Microbiology, or related discipline.

• Minimum 5 years of experience supporting pharmaceutical, biotechnology, medical device, biologics, or other GxP-regulated organizations.
• Direct experience performing Data Integrity Assessments, Data Integrity remediation activities, Part 11 Assessments, periodic reviews, and/or Computerized System Validation (CSV) activities within a regulated environment.
• Strong understanding of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Data Integrity principles, Computerized System Validation, and Risk-based compliance methodologies
• Experience evaluating computerized laboratory systems and laboratory instrument software within a regulated environment.
• Strong technical writing and documentation skills.
• Ability to independently facilitate discussions with laboratory personnel, Quality Assurance, Validation, Information Technology, and Operations teams.
• Demonstrated ability to work independently, prioritize workload, and manage multiple assignments simultaneously.
• Must comply with the company Code of Conduct, policies and regulatory standards.

Desired Laboratory Systems Experience

Candidates should have experience supporting, assessing, validating, configuring, or maintaining computerized laboratory instrumentation and associated software in a GxP-regulated environment. Experience with one or more of the following is highly desirable:

• PCR and molecular biology platforms
• Spectroscopy and spectrophotometry system
• Mass Spectrometry systems,
• Automated cell analysis or cell counting systems
• Laboratory analytical instruments generating electronic records
• Instrument control and data acquisition software
• Computerized laboratory systems subject to 21CFR Part 11 requirements

Preferred Qualifications

• Experience developing or reviewing Configuration Specifications, Functional Specifications, Design Specifications, assessment reports, and other computerized system lifecycle documentation.
• Experience with electronic document management systems such as Veeva.
• Familiarity with GAMP 5 principles and risk-based computerized system compliance approaches.
• Previous consulting experience supporting multiple projects or clients.

What Will Make Someone Successful In This Role

• Strong laboratory systems background.
• Ability to understand how regulated laboratory data is generated, processed, reviewed, approved, retained, archived, and retrieved throughout the complete data lifecycle.
• Experience identifying practical remediation solutions in addition to compliance gaps.
• Ability to independently conduct assessments and prepare high-quality client-facing deliverables with minimal supervision.
• Strong attention to detail, organization, communication, and project execution skills.

In order to be considered, please answer the following questions:

• How many years of experience do you have performing laboratory Data Integrity assessments in a GMP/GLP-regulated environment?
• How many years of experience do you have assessing computerized systems for compliance with 21 CFR Part 11?, How many years of hands-on experience do you have assessing computerized systems for compliance with 21 CFR Part 11?, * pharmaceutical: 5 years (Required)
• CSV: 2 years (Preferred)
• Data Integrity: 2 years (Preferred)

The ideal candidate will be comfortable working independently, interacting with laboratory personnel, Quality Assurance, Validation, Information Technology, Engineering, and system owners, and documenting technical findings in a clear and defensible manner. The candidate must be capable of assessing both technical and procedural controls associated with the lifecycle of GxP data. The position will be contract driven with an initial contract length of 6 months, with possible extension. Compensation will be hourly based at very competitive top rate., Pay: $70.00 - $90.00 per hour

Expected hours: 40.0 per week

Application Question(s):

• In order to be considered, please answer the following question:

How many years of experience do you have performing laboratory Data Integrity assessments in a GMP/GLP-regulated environment?

• In order to be considered, please answer the following question