Aditi Consulting · 2 days ago
Senior Process Development Associate
Thousand Oaks, CA
Contract
Onsite
Mid, Senior Level
$35/hr - $37/hr
2+ years expAditi Consulting is seeking a detail-oriented and highly disciplined Senior Associate to perform data verification for a Rapid Analytics Lab. The role focuses on verifying Notebook entries and chromatographic data to ensure compliance with reporting requirements and Good Documentation Practices.
AppsConsultingInformation TechnologySoftware Engineering
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
Required
Bachelor's 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
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
Preferred
2+ years of experience in data verification and analytical laboratory operations
Minimum: Bachelor's 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
Dental
Vision benefits
Health savings accounts with qualified medical plan enrollment
10 paid days off
3 days paid bereavement leave
401(k) plan participation with employer match
Life and disability insurance
Commuter benefits
Dependent care flexible spending account
Accident insurance
Critical illness insurance
Hospital indemnity insurance
Accommodations and reimbursement for work travel
Discretionary performance or recognition bonus
Sick leave
Mobile phone reimbursement
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
1001-5000 employees
H1B Sponsorship
Aditi Consulting 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (44)
2023 (25)
2022 (26)
2021 (24)
2020 (30)
Funding
Current Stage
Late StageLeadership Team
Raja Narayana
President & CEO
Pradeep Singh
Chairman
Recent News
bloomberglaw.com
2025-10-16
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