Quality Control Analyst I - Microbiology

Rentschler Biopharma•Milford, MA

5d•Hybrid

About The Position

The Quality Control Analyst I in Microbiology performs microbiological analysis of in-process, release, and stability samples to support manufacturing. In addition, the QC Analyst may cross-train with the QC Analytical team to support in-process analytical testing. Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.

Requirements

Bachelor’s Degree in Microbiology, Biological Sciences are related scientific discipline
Knowledge of aseptic technique
Proficient in use of computer systems to collect and record data
Knowledge of basic chemical and biological safety procedures
Must be able to read and follow detailed written instructions like Standard Operating Procedures (SOPs)
Communicate effectively, in writing and verbally, to staff at all levels of the organization including staff with varying levels of technical and scientific knowledge

Nice To Haves

1+ years of Quality and/or lab experience
Quality Control experience in a CGMP manufacturing facility preferred

Responsibilities

In accordance with test method SOP’s, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, and Media performance
Perform environmental monitoring of cleanrooms and water system sampling
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, Eu. Ph., GLP, GDP, QSR, and CGMP regulations
Always maintain sample tracking and integrity until analyses are reviewed
As part of the Microbiology team, perform general lab maintenance.
Order supplies as needed, store materials as indicated and discard expired materials as per manufacturer or test method recommendations
Support internal and external lab audits as required, including representing QC to auditors as needed