Quality Control Analyst I - Microbiology

Rentschler Biopharma • Milford, MA

6d • 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) and 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

Benefits

• annual discretionary bonus program
• medical insurance
• 401K program

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level