QC- Laboratory Analyst (Licensed Chemist)

• Prepares verification protocols and reports as required.
• Revises SOPs and keeps track of daily schedule.
• Performs test verifications when required and provides training to laboratory technologists as needed.
• Keeps track of the reagents, standards and supplies inventory in the QC laboratory generate the purchase requisition request as needed.
• Assures that files and records are maintained up to date.
• Attends QC or development meetings as needed.
• Supports EHS program to assure compliance with safety policies.
• Performs compendia} test data verification under minimum supervision
• Interprets results obtained during method development and troubleshoots tests as needed.
• Performs review of non-conventional testing of solid dosage forms, capsules and others forms, such as: force degradation, tablet scoring, solubility, method validation, method development analysis, bioequivalence dissolution analysis with different medias, among others.
• Performs tests review for API, raw materials, in-process samples, research samples, finished product and stabilities following analytical specifications, protocol specifications, procedures, and/or instructions as applicable.
• Records data in an orderly manner following laboratory rules and SOP's calculates results as required, compares results with specifications and seeks further direction when are not met.
• Performs laboratory housekeeping always.
• Prepares progress reports.
• Assists in or carries out work of an experimental nature under limited supervision.
• Works with instruments of an advanced and/or sophisticated nature and performs troubleshooting work when required.
• Assists in data verification and informs supervisor if any discrepancy found.
• Keeps records and files up to date and assures that information is available at all times.
• Ensures that any waste (hazardous, non-hazardous or special waste) generated as part of his/her responsibilities are handled in compliance with applicable environmental regulations and in accordance to establish SO P's for handling waste.
• Documents on a timely manner in the corresponding laboratory logbooks and laboratory notebooks all the information regarding to the testing activities.
• Write/assist in laboratory protocols deviation report
• Performs other duties as assigned.

• Bachelor's Degree in Chemistry with License.
• Five years (5) or more of experience in a cGMP regulated analytical laboratory.

• Experience in method validation (preparation of protocols and reports), analytical technology transfer and cleaning validation.
• Knowledge in FDA, GMP, ICH and USP requirements for method, cleaning validation and transfer
• Computer literate
• Excellent communication skills in English and Spanish.

• 100% On-site
• 3 months (1st Contract)
• Administrative Shift (available to work flexible shifts, including weekends and overtime, as required).
• Temporary Contract

CIS International LLC