Quality Control Analyst II, Microbiology

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

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. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

Duties And 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
  
  
  

Qualifications

• 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
  
  
  

Preferred Qualifications

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

Working Conditions

• 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)
  
  
  

Physical Requirements

• 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