Job Description
Conduct Analysis in compliance with cGMP requirements, compendia standards, and
internal procedures
Maintain accurate record of analysis and perform documentation to company standards
Prepare test solutions, volumetric solutions, and samples used in analysis
Performs assigned sampling, physical, chemical tests and assay on raw materials, active
pharmaceutical ingredients, in-process, finished, and stability products analysis in an FDA
regulated lab environment
Uses a variety of analytical instruments such as HPLC, GC, Dissolution, Malvern, IR, Auto
Titrator, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer etc.
Perform analysis with a practical understanding of the test procedure and instrument
operation
Perform laboratory analysis right first time, contemporaneous documentation, analyze and
document the results
Conducts laboratory investigation under the supervision of laboratory manager.
Performs maintenance and calibrations of laboratory instruments /equipment
Complies with all regulatory/ in-house requirements may include but not be limited to
safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation
Perform analysis with a practical understanding of the test procedure and instrument
operation
Maintain required level of training needed to perform a GMP task
Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned
Notify manager immediately of nonconforming data or unexpected occurrences
Organize work schedule to complete assigned tasks efficiently and on schedule
Work under direction provided by supervisor and Other duties as assigned
About Synoverge Consultants
Synoverge Consultants
synovergeconsultants.com
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