Description:
Payrate: $24 usd /hr
Shift 2 y 3
JOB PURPOSE:
Provides technical support to the chemistry laboratory personnel. Performs and/ or review/ approve chemistry laboratory tests to avoid delay in the release of the product, assuring a quality and safety work.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible to achieving accurate laboratory testing results lies with the analyst who is performing the test.
Should be aware of potential problems that could occur during the testing process and should watch for problems that could create inaccurate results.
Approves and reviews documents, assures that the Department complies with internal and external regulations and standards.
Performs any work to avoid the delay in the release of the product.
Analyzes purchase raw materials against established procedures assuring compliance with all regulations and specifications.
Review and/or approval of laboratory documentation.
Must follow the current Good Manufacturing Practices (cGMP's), current Good Documentation Practices (cGDP's) and current Good Laboratory Practices (cGLP).
Audits chemical test procedures, retests, additional testing's and SOP's in the laboratory.
Requests and order all materials required in the laboratory on timely basis to assure an efficient performance (make request of accessories, equipment, reagents, etc.; including the issuance of purchase orders).
Initiates and implement changes or new chemical procedures including data gathering.
Capable to develops, modifies and analyzes protocols and procedures as required.
Prepares general material and solutions needed for laboratory tests, as required.
Sanitize the work areas before and after operations.
Keeps the work area in the cleanest and order conditions.
Should be able to work within minimum supervision.
Should be able to work with many projects and handle multiple tasks at the same time.
Willing to work extra hours, at any shift when its required, on Holidays and during special periods (eg. shutdowns, internal and external audits, special projects).
Performs statistical data evaluation (such as: Water analysis, etc.), as required.
Run and troubleshoots the laboratory computer systems, as requires.
Performs laboratory tests; and prepares and evaluates control charts, using laboratory data.
Team worked oriented and participate in laboratory audits.
Should be able to work on special projects as assigned. Complies with the established milestones for projects.
Supports training activities in SOP's and changes, when required.
Prepares monthly, quarterly and annual reports for the chemical laboratory indicators as required.
Performs internal audits to areas of responsibility and document findings and suggestions to improve processes.
Performs laboratory Investigations, when requested.
Additional task can be assigned as business needs.
Available to work in extended shift and weekend as needed.
Education:
B.S. in Chemist (Master Degree desirable but not required) Puerto Rico Chemist License (preferred).
Preferred Qualifications:
At least two years of experience in a Pharmaceutical Industry (preferable).
Strong knowledge in HPLC, Atomic Absorption, FT-IR, Karl Fisher, UV/VIS, TOC Analyzer, Polarimeter.
Strongly oriented to GMP's, GLP's, OSHA, US Pharmacopeia, EP, Good troubleshooting resolution techniques.
Strong knowledge in LIMS etc.
Skills:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, internal and external audits.
Fully bilingual (English and Spanish languages).
Ability to communicate, read, write and understand English/Spanish languages.
Work Methodology:
On-site
9 months 1st contract
2nd and 3er shift
will vary based on the need of the project. Weekends and overtime may also be required.
