For Chemist Operations Support services in the Laboratory area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s Degree in Chemistry & four (4) year of experience within a Laboratory in the Regulated Industry.
Bilingual: English & Spanish.
Shift: Administrative and according to business needs.
Chemist License.
Experience in:
Equipment: HPLC, UV, IR, etc.
Chromatography (Empower system), USP, EP, etc.
Aseptic procedures.
Compliance requirements, cGMP, GLP and FDA regulations.
The Personality Part:
If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
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.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
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Numbers & Facts
Location
Dorado
Website
http://www.fitspr.com
Skills
Analysis Skillsunmatched
Asepsisunmatched
Biotech and Pharmaceuticalunmatched
Chemistryunmatched
Chromatographic Systemsunmatched
Construction Engineeringunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Customer Satisfactionunmatched
Customer Support/Serviceunmatched
Dosage Formsunmatched
English Languageunmatched
Environmental Monitoringunmatched
FDA Requirementsunmatched
GLP (Good Laboratory Practices)unmatched
Government Regulationsunmatched
High Performance Liquid Chromatography (HPLC)unmatched
IR (Infrared)unmatched
Laboratoryunmatched
Laboratory Analysisunmatched
Manufacturingunmatched
Manufacturing Analysisunmatched
Medical Equipmentunmatched
Multilingualunmatched
Operational Supportunmatched
Osmolarityunmatched
Procedure Developmentunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Spanish Languageunmatched
Specimen Collectionunmatched
Staff Trainingunmatched
Sterilizationunmatched
Surveillanceunmatched
Time Managementunmatched
🎯
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