Quality Control Analyst, Microbiology (Contract - 3rd ...

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies. We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together! 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 1+ 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

Created: 2024-11-05