Senior Process Development Associate

Aditi Consulting; Thousand Oaks (CA); Presencial; USD 48 216 - 50 971; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental, and vision benefits

401(k) plan participation with employer match

Paid days off and bereavement leave

Discretionary performance bonus

Resumo da oferta

A leading consulting firm seeks a detail-oriented Senior Associate to perform data verification for a Rapid Analytics Lab. This role involves verifying notebook entries, chromatographic data, and ensuring compliance with Good Documentation Practices. The ideal candidate should have a Bachelor's degree in a scientific discipline, experience with Empower and Chromeleon systems, and a strong understanding of data integrity principles. This position offers competitive hourly pay and opportunities for career growth in a dynamic analytical environment.

Qualificações

• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, or related field.
• Experience with laboratory information systems is essential.
• Familiarity with chromatographic techniques and data integrity principles.

Responsabilidades

• Perform verification of analytical data packages.
• Ensure compliance with internal SOPs and regulatory expectations.
• Identify discrepancies in data and collaborate to resolve issues.

Conhecimentos

Analytical expertise

Attention to detail

Organizational skills

Communication skills

Formação académica

Bachelor’s degree in a scientific discipline

Ferramentas

Empower

Chromeleon

Electronic Laboratory Notebook systems (ELN/LIMS)

Descrição da oferta de emprego

Base pay range: $35.00/hr – $37.00/hr

We are 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, 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.

Basic Qualifications

• 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.

Preferred Qualifications

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

Skills

• 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.

Pay Transparency

The typical base pay for this role across the U.S. is $35.00 – $37.00/hour. Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts are determined by factors including your relevant skills, education, and experience. Full‑time employees may select from different benefits packages that may include medical, dental, and 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, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement are provided based on state or local law.

Other Information

Seniority level: Entry level

Employment type: Contract

Job function: Research, Analyst, and Information Technology