Analytical Method Development Contractor

Yoh Life Sciences

Yoh Life Sciences is hiring for an Analytical Method Development (AMD) Documentation Contractor in Bristol, PA. The contractor plays a critical role in supporting analytical method development and qualification activities through rigorous documentation, data analysis, and technical laboratory support. This position is heavily focused on ensuring that all analytical development work is thoroughly documented, traceable, and compliant with current Good Documentation Practices (cGDP).

The Associate will support method development and method qualification studies by organizing templates, capturing and analyzing data, identifying trends or deviations, and assisting in troubleshooting analytical methods. This role requires strong technical writing skills, analytical thinking, attention to detail, and hands‑on experience with analytical instrumentation.

Location: Bristol, PA

Duration: 3 months

Pay: $30‑40/hr DOE

Shift: M‑F 8am‑5pm

• Document analytical method development and method qualification activities in laboratory notebooks and controlled templates in accordance with company policies and cGDP standards.
• Prepare, review, and maintain method development reports, qualification protocols, summary reports, and supporting documentation.
• Develop and manage standardized documentation templates for method development and qualification studies.
• Ensure complete traceability of experimental data, instrument parameters, calculations, and observations.
• Maintain organized, audit‑ready documentation in compliance with regulatory and quality requirements.

• Collect, compile, and analyze analytical data generated during method development and qualification studies.
• Evaluate method performance characteristics (e.g., precision, accuracy, linearity, robustness, specificity) and document findings.
• Identify data trends, outliers, and deviations; assist in determining root cause of atypical results.
• Collaborate with analytical scientists to troubleshoot methods and recommend corrective actions.
• Document investigations, experimental adjustments, and outcomes clearly and accurately.

• Operate and support analytical instrumentation used in method development (e.g., HPLC/UPLC, UV‑Vis, plate readers, pH meters, balances, and other common analytical equipment).
• Record instrument parameters, system suitability results, and maintenance activities in accordance with cGDP.
• Perform routine equipment checks (e.g., balances, storage chambers) and ensure documentation is complete and compliant.
• Support instrument qualification activities by organizing and maintaining required documentation.

• Serve as the primary AMD contact for sample receipt, labeling, tracking, and inventory management.
• Track sample shipments and maintain accurate sample inventory logs.
• Prepare buffers and solutions used in the AMD laboratory, ensuring proper documentation of preparation records.
• Perform routine analytical testing on samples from process development teams and document results.
• Inventory laboratory supplies, consumables, chemicals, and reagents; ensure proper disposal of expired materials.
• Maintain laboratory organization, cleanliness, and readiness for audits.

• Effectively communicate analytical findings and data summaries to area management and process development teams.
• Record all laboratory activities in logbooks and notebooks following current Good Documentation Practices (cGDP).
• Operate to the highest ethical and professional standards, ensuring data integrity and compliance at all times.

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related scientific discipline required.

• 1–4 years of experience in analytical method development or analytical laboratory support in a pharmaceutical or biotechnology environment preferred.
• Demonstrated experience documenting method development or method qualification studies.
• Experience working in a regulated environment (GMP/GLP) strongly preferred.
• Experience with…