Perform routine calibration, performance verification, and system suitability testing of High-Performance Liquid Chromatography (HPLC) and Tandem Mass Spectrometry (MS/MS) instruments to ensure compliance with regulatory and quality standards (e.g., cGMP, GLP, FDA, ISO 17025).

Document calibration activities and ensure traceability of standards used.

Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with regulatory and quality standards.

Ensure proper configuration, validation, and security of instrument control and data acquisition software (e.g., Empower, MassLynx, Analyst).

Adhere to ALCOA+ principles for data integrity and compliance with 21 CFR Part 11 requirements.

Perform routine calibration and verification of Hamilton instruments, including Microlab STAR, Microlab NIMBUS, and VANTAGE liquid handlers, ensuring optimal performance.

Utilize gravimetric, photometric, and dye-based methods to validate liquid handling accuracy and precision.

Maintain calibration logs and ensure traceability of reference standards used in calibrations.

Perform scheduled preventive maintenance, including cleaning, lubrication, and replacement of consumable parts (e.g., syringes, tubing, filters, and probes).

Diagnose and troubleshoot mechanical, electronic, and software issues in Hamilton systems to minimize instrument downtime.

Ensure proper configuration, validation, and security of Hamilton VENUS and INSTINCT software used for liquid handling automation.

Requirements

Bachelor of Science degree, in Chemistry, Biological Science or closely related field of study.

Two years' experience as Validation Scientist in preparing and analyzing samples using HPLC and UPLC . instrumentation, developing analytical methods across a range of techniques, and performing comprehensive method validation.

Skills in High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Dissolution, UV-Vis, IR, Particle Size Analyzer, Karl Fischer (KF) Autotitrator, and Compendial monographs.

Proficiency in maintenance and calibrations on laboratory instruments/equipment.

Send resume to: Resolian f.k.a. Alliance Pharma, Inc. 17 Lee Blvd. Malvern, PA 19355. Ref # ABPA2025

Resolian

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