About this role
KEY RESPONSIBILITIES
- Develop and optimize analytical methods for pharmaceutical, OTC drug, consumer healthcare, personal care, or related products.
- Plan, author, execute, and complete analytical method development, validation, verification, and transfer protocols and reports.
- Evaluate accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, robustness, and system suitability, as applicable.
- Design scientifically justified experiments to improve method performance, sensitivity, reproducibility, efficiency, and ease of routine use.
- Perform technical and statistical evaluation of calculations, chromatograms, spectra, audit trails, electronic records, and supporting documentation.
- Coordinate method transfers between internal laboratories and qualified external laboratories, including comparative testing and discrepancy resolution.
- Operate, maintain, and troubleshoot HPLC/UHPLC, GC, UV-Vis, FTIR, potentiometer and other applicable analytical equipment.
- Prepare and maintain analytical methods, specifications, SOPs, work instructions, validation plans, risk assessments, protocols, reports, and controlled forms.
- Investigate OOS, OOT, atypical, and invalid results and document scientifically justified root causes, conclusions, and corrective or preventive actions.
- Support deviations, change controls, CAPA, laboratory investigations, effectiveness checks, and continuous improvement initiatives.
- Provide technical support for instrument qualification, calibration, preventive maintenance, repair, software upgrades, and vendor activities.
- Train and qualify laboratory personnel on new or revised methods, instruments, software, and procedures.
AGILENT OPENLAB CDS PLUS - REQUIRED KNOWLEDGE OR EXPERIENCE
- Hands-on experience using Agilent OpenLab CDS Plus for sequence setup, data acquisition, processing methods, calculations, reporting, and controlled electronic records.
- Ability to review chromatographic data, metadata, audit trails, processing changes, system suitability, and electronic records for completeness and data integrity.
- Experience troubleshooting instrument-to-software communication, acquisition failures, processing issues, and report-generation concerns.
- Working knowledge of role-based access, electronic signatures, audit trails, backup and recovery, and computerized-system lifecycle controls in a regulated laboratory.
- Experience supporting OpenLab implementation, configuration, validation, upgrade, migration, or periodic review is strongly preferred.
QUALITY, COMPLIANCE & DATA INTEGRITY
- Follow current GMP, Good Documentation Practices, laboratory safety requirements, and ALCOA+ data integrity principles.
- Apply relevant analytical procedure development and validation concepts, including ICH guidelines , applicable USP requirements, and internal procedures.
- Support compliance with electronic records and electronic signature requirements, including 21 CFR Part 11 principles and applicable computerized-system controls.
- Support internal audits, customer audits, regulatory inspections, product transfers, and laboratory remediation activities.
- Maintain complete, accurate, contemporaneous, attributable, legible, original, and traceable laboratory and validation records.