Quality Control Analyst, Microbiology; 2nd Shift

Quality Control Analyst, Microbiology (2nd Shift - 6+ month contract)

Apply to the Quality Control Analyst, Microbiology (2nd Shift – 6+ month contract) role at Rentschler Biopharma
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Advancing medicine to save lives. Together.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family‑owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best‑in‑class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family‑owned company, we live by the motto:
Many hands, many minds – ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities.

• In accordance with test method SOPs, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, and Media performance
• Perform environmental monitoring of clean rooms 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

• Bachelor’s Degree in Microbiology or related biological science 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 such as SOPs and communicate effectively, in writing and verbally, to staff at all levels of the organization

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

• Laboratory environment working with chemical reagents and analytical equipment
• Personal Protective Equipment must be worn as required
• Entry into utilities rooms for water sampling
• Clean Room gowning and scrubs
• Normal office working conditions: computer, phone, files, fax, copier
• Minimum travel required (Less than 10% domestic)

• Participation in a holiday and weekend rotation is required
• Frequent lifting up to 25 lbs
• Frequent standing/walking to work in lab environment for extended periods
• Frequent sitting for extended periods to use computer

Associate

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Biotechnology Research and Pharmaceutical Manufacturing

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