Data Verifier (Regulatory Filing Support)/ Process Development Sr Associate

As a Process Development Sr Associate based in Newbury Park, California , you will operate in a contract capacity for one year (potential to extend) within a standard 9-to-5 work schedule. This role requires a Bachelor’s degree and offers a competitive salary range of $35.00 to $41.87 per hour.

Job Summary

• We are 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 will focus on verifying Notebook entries, Empower chromatographic data, and Chromeleon instrument data to confirm alignment with reporting requirements and Good Documentation Practices (GDP). The ideal candidate possesses strong analytical expertise, exceptional diligence, and a deep understanding of expectations for data review.

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.

Qualifications

Basic Qualifications

• 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 Qualifications

• 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.

Key Competencies

• Exceptional attention to detail and accuracy
• Strong organizational and prioritization skills
• Ability to work independently while collaborating effectively with analysts, SMEs, and regulatory teams
• Professional communication and documentation skills
• Commitment to data integrity and continuous improvement

skills: High Pressure Liquid Chromatography (HPLC), Electronic Laboratory Notebook (ELN), Good Documentation Practices (GDP), Food and Drug Administration (FDA), International Council for Harmonization (ICH)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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