Summary:

Supports the development and validation of methods to test new products manufactured at the site. Performs testing of experimental, confirmation and registration lots, stabilities and new supplier certifications. Participates in the transfer of analytical technology to the commercial laboratories with attention to details.

Primary Functions:

1. Receives and logs in samples, review analytical data and prepares certificate of analysis.
2. Prepares verification protocols and reports as required.
3. Revises SOPs and keeps track of daily schedule.
4. Performs test verifications when required and provides training to laboratory technologists as needed.
5. Keeps track of the reagents, standards and supplies inventory in the QC laboratory generate the purchase requisition request as needed.
6. Assures that files and records are maintained up to date.
7. Attends QC or development meetings as needed.
8. Supports EHS program to assure compliance with safety policies.
9. Performs compendia} test data verification under minimum supervision
10. Interprets results obtained during method development and troubleshoots tests as needed.
11. 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.
12. 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.
13. 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.
14. Performs laboratory housekeeping always.
15. Prepares progress reports.
16. Assists in or carries out work of an experimental nature under limited supervision.
17. Works with instruments of an advanced and/or sophisticated nature and performs troubleshooting work when required.
18. Assists in data verification and informs supervisor if any discrepancy found.
19. Keeps records and files up to date and assures that information is available at all times.
20. 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.
21. Documents on a timely manner in the corresponding laboratory logbooks and laboratory notebooks all the information regarding to the testing activities.
22. Write/assist in laboratory protocols deviation report
23. Performs other duties as assigned.

Secondary Functions:

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

Education Requirement:

• 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.

Work Methodology:

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