Bilingual Laboratory Chemist — Aseptic & GMP Compliance

FITS LLC

Dorado (PR)

On-site

USD 60,000 - 90,000

Full time

14 days+

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Job summary

FITS LLC in Dorado, PR seeks a Chemist for Operations Support in the Laboratory area. The role requires a Chemistry degree, a chemistry license, and 4 years of regulated-lab experience. Bilingual in English and Spanish, with expertise in HPLC, Empower chromatography, and aseptic methods.

Administrative shift based on business needs. You will perform analyses to release manufactured products, monitor environmental conditions, and ensure cGMP/GLP compliance while documenting actions and training

Qualifications

Bachelor’s Degree in Chemistry and four year of experience within a Laboratory in the Regulated Industry.
Bilingual English & Spanish.
Shift: Administrative and according to business needs.
Chemist License.
Experience in: HPLC, UV, IR; Chromatography (Empower system), USP, EP; Aseptic procedures.
Compliance requirements, cGMP, GLP and FDA regulations.

Responsibilities

Performs laboratory analysis or tasks following established procedures and in full compliance with current governmental regulations, official compendia and any other policy regulation to generate reliable and timely results, to comply with release due date, reduce cycle time, and provide internal/external customer satisfaction.
The analysis is bacterial endotoxin, sterility test, bioburden / microbial limit, growth promotion, particulate matter to parenteral products, microbial identification, pH test, osmolality, density, protein concentration, and other analysis related to the release of the products being manufactured.
In addition, do microbial analyses of manufacturing utilities (i.e. water, clean condensate, compressed air, nitrogen, etc.),
Preparation and sterilization of materials needed for the analysis such as culture media and the dehydrogenation/sterilization of glassware.
Environmental surveillance of aseptic and oral dosage form manufacturing and packaging facilities which includes viable (air, surface personnel) and non-viable monitoring.
Generates environmental trends and graphs of the controlled environments, posts them in the manufacturing areas, and discusses them with manufacturing personnel.
Audit of aseptic techniques and adequate behavior within the controlled manufacturing environment. Documents if necessary inadequate behavior and generates audit corrective actions if required.
Audit the controlled areas and utilities' physical conditions (housekeeping) and generate audit corrective actions if required.
Trains the manufacturing personnel in environmental monitoring sampling and other aseptic processing techniques.
Oversees sample collection from production areas if manufacturing operators are responsible for performing the task.