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Randstad USA · 5 hours ago

Data Verifier (Regulatory Filing Support)

Thousand Oaks, CA

Contract

Onsite

Entry, Mid Level

$35/hr - $41.87/hr

2+ years exp

Randstad USA is seeking a detail-oriented and highly disciplined Senior Associate to perform data verification for a Rapid Analytics Lab located at Thousand Oaks California. This role focuses on verifying analytical data to ensure compliance with reporting requirements and Good Documentation Practices (GDP). The ideal candidate will possess strong analytical expertise and a deep understanding of data review expectations.

ConsultingHuman ResourcesInformation TechnologyRecruiting

H1B Sponsor Likely

Responsibilities

Perform comprehensive verification of analytical data packages, including Notebook records, Empower chromatographic results, and Chromeleon sequences and reports

Confirm data accuracy, traceability, and compliance with internal SOPs and regulatory expectations (e.g., FDA, EMA, ICH)

Ensure that data used in regulatory filings are complete, consistent, and appropriately linked to source systems

Identify discrepancies or omissions in data packages and work collaboratively with laboratory analysts and technical leads to resolve issues

Verify metadata, audit trails, instrument parameters, and processing methods to ensure appropriate data governance and ALCOA+ principles

Participate in process improvement initiatives related to data verification workflows and digital system integration

Maintain organized, inspection-ready documentation to support internal audits and health authority inspections

Qualification

EmpowerChromeleonChromatographic techniquesData integrity principlesDocumentation PracticesProfessional communicationAttention to detailOrganizational skills

Required

Bachelors degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biotechnology, Analytical Sciences) or equivalent combination of education and relevant experience

Experience working with laboratory information systems, including Empower and/or Chromeleon, and electronic Laboratory Notebook systems (ELN/LIMS)

Strong understanding of chromatographic techniques (Capillary Electrophoresis/HPLC/UPLC), data processing, and instrument workflows

Demonstrated familiarity with data integrity principles

Preferred

2+ years of experience in data verification and analytical laboratory operations

Minimum: Bachelors degree

Direct experience in preparing or supporting data for regulatory filings

Knowledge of analytical method validation, transfer, release, and stability testing

Ability to clearly communicate data issues, trends, and resolutions to cross-functional teams

High aptitude for working with digital systems, data governance tools, and structured documentation

Benefits

Medical

Prescription

Dental

Vision

AD&D

Life insurance offerings

Short-term disability

401K plan

Company

Randstad USA

Glassdoor3.8

Randstad US is a wholly owned subsidiary of Randstad Holding nv, a global provider of human resources solutions.

Founded in 1998

Atlanta, Georgia, USA

1001-5000 employees

http://randstadusa.com

H1B Sponsorship

Randstad USA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (754)

2022 (776)

2021 (1143)

2020 (1749)