Laboratory Technicians (Chemist- Analyst)

• Performs non-conventional testing of solid dosage forms, capsules and others forms under the supervision of the PD Analytical Development Scientist, such as: force degradation, tablet scoring, solubility, method validation, method development analysis, bioequivalence dissolution analysis 3 biological medias, among others.
• Performs tests for API, raw materials, in-process samples, research samples, finish product and stabilities following analytical protocol specifications, procedures, and/or instructions as applicable.
• Revises SOPs and complete daily schedule.
• Keeps track of the reagents, standards and supplies inventory in the Product Development laboratory, generate the purchase requisition request as needed.
• Assures that files and records are maintained up to date.
• Attends development meetings as needed.
• Supports EHS program to assure compliance with safety policies.
• Performs laboratory housekeeping always.
• Documents on a timely manner in the corresponding laboratory logbooks and laboratory notebooks all the information regarding the testing activities.
• Performs any other duties as assigned.
• Write/assist in laboratory protocols deviation report.
• Handle controlled substances.
• Assists in data verification and informs supervisor if any discrepancy found.
• Enters tests results in the database and informs supervisor if any discrepancy is found.

• Works with instruments of an advanced and/or sophisticated nature and performs troubleshooting work when required.
• 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.

• Bachelor's Degree in Chemistry.
• Two to four years or more of experience in a cGMP regulated analytical laboratory.

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

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

CIS International LLC