Entry-level Biologist with an exceptionally broad knowledge and technical skills in microbiology and chemistry.
• Set-up, clean, sanitize and prepare room and equipment for formulation and filling process.
• Perform and monitor critical processes and execute routine validation protocols.
• Provide quality oversight to ensure that production and testing results are complete, accurate, and detailed according to
written procedures.
• Review documentation to ensure is accurate according to written procedures and cGMP.
• Receive, store, dispense, deliver, transfer, reconcile, cycle count, and ship materials per cGMP procedures and
regulations.
• Prepare manufacturing equipment through the management of Clean and Steam in Place, Clean Out of Place (COP), Parts
Washer, Autoclave, and Aseptic Assemblies.
• Management of RT-Report, Electronic Batch Record (eBR), PCS (Process Control System), LIMS (Laboratory Information Management Systems) and Forms for manual input.
• Collect samples for TOC (Total Organic Carbon) analysis.
• Assembly and disassembly of filters for manufacturing processes.
• Conduct integrity test for filters (e. g. Hydrophilic and Hydrophobic filters).
PCR (Polymerase Chain Reaction)
Gram Staining
Highly detailed oriented
Aseptic techniques (eg, sterilization, disinfection, dilution)
Strong organizational skills
Safety Awareness
Ability to work collaboratively with a high degree of independence
Culture techniques (e g, isolation, inoculation, inspection and incubation)
Sample collection (eg, TOC (Total Organic Carbon)
Computer systems: LIMS, eBR
Microsoft Word, Excel, Power Point
Good manufacturing, lab, and documentation practices
Bilingual: English and Spanish (native speaker)
Collection, management, and reporting of scientific data
Analytical methods (eg pH, conductivity, osmolality, oxidation)