Laboratory Chemist

FITS, LLC; Dorado (PR); On-site; USD 55,000 - 85,000; Full time

Job summary

FITS, LLC is seeking a Chemist Operations Support in the Laboratory to perform analyses and support manufacturing release. The candidate should have a chemistry degree and several years in a regulated lab, with hands-on experience in HPLC, UV, IR and chromatographic methods using Empower and USP/EP guidelines.

The role includes aseptic procedures, environmental monitoring, and ensuring compliance with cGMP/GLP and FDA regulations while supporting production and quality teams in a dynamic

Qualifications

• Bachelor’s degree in Chemistry with 4 years of lab experience in a regulated setting.
• Experience with HPLC, UV, IR and related lab instrumentation.
• Experience with chromatography (Empower) and associated compendia (USP/EP).
• Aseptic procedures and regulatory compliance (cGMP/GLP/FDA).

Responsibilities

• Performs laboratory analyses following established procedures to generate reliable results.
• Conducts tests such as endotoxin, sterility, bioburden, pH, osmolality, and protein concentration.
• Performs environmental monitoring and prepares materials for analysis.
• Maintains compliance with regulatory requirements and documents results.

Skills

Chromatography

Aseptic procedures

Regulatory compliance

Environmental monitoring

Laboratory analysis

Education

Bachelor’s degree in Chemistry

Tools

HPLC

UV

IR

Empower system

Job description

For Chemist Operations Supportservices 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 RegulatedIndustry.
• Shift: Administrative and a ccording to business needs.
• 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 companydifferent 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 industryclients with top-notch quality talent.We're FITS!