QC Microbiologist I Sun to Wed 3PM to 1:30 AM

PCI Pharma Services•Bedford, NH

1d•Onsite

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Requirements

Exceptional organizational skills
Following written instructions
Detail oriented
Ability to multi-task
Word Processing, XL spreadsheets
Competent in MS Office
Professional verbal and written communication skills required
High school diploma with 1-2 years of experience in QC Microbiology or Environmental Monitoring, or a Bachelor’s degree in biology and 0-1 year of experience.

Nice To Haves

Training team members with less experience will be encouraged for this role.

Responsibilities

Conducts sampling of product environments, and/or facility clean utilities, as per approved procedures.
Tests collected samples for the following: TOC/Conductivity, Bioburden, and Endotoxin.
Performs quality control testing of in-process pharmaceutical products.
Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines.
Completes routine environmental monitoring of classified aseptic and non-aseptic areas within manufacturing facilities, as per approved procedures over multiple local production sites. Sampling includes viable and non-viable particulates, as well as contact plates.
Completes environmental monitoring of clean rooms and operations personnel during manufacturing, as per approved procedures over multiple local production sites.
Performs utility sampling, as per approved procedures over multiple local production sites- including purified water systems, water for injection systems, compressed air, and clean steam systems.
Conducts coliform, bioburden, endotoxin, TOC, conductivity, and appearance testing for utility samples as well as pharmaceutical product samples.
Performs lab maintenance tasks, such as routine cleaning of bench spaces and biological safety cabinets, stocking of supplies, and general organization.
Completes daily and weekly assigned tasks in the Microbiology Laboratory, including product bioburdens, biological indicator testing, plate incubation and enumeration.
Performs growth promotion for media, and growth verification for prepared microorganism cultures.
Prepares microbial growth for shipment and identification as required.
Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation in compliance with GDP guidelines.
Records data and assay performance with a high attention to detail in either paper forms and/or electronic documentation systems.
Completes data verification checks and/or inputs of trended data.
Event reporting in the quality tracking system.
Review documentation for tasks performed by the QC department and resultant data for accuracy and traceability.