QC Laboratory Analyst

• 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 compendial 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. N
• 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 SOP'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.

• Supports revision of QC SOPs and preparation of analytical methods as needed for API, Excipients and Finished Product as needed.

• Bachelor's Degree in Chemistry
• Licensed Chemist
• 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

• Flexible to work flexible shifts including weekends
• Work under pressure and adapt to dynamic changes of working schedule and shift

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