Quality Control Analyst

Quality Control Analyst I in MicrobiologyAdvancing 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.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.Duties and ResponsibilitiesIn accordance with test method SOP's, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, and Media performancePerform environmental monitoring of cleanrooms and water system samplingMaintain data integrity and ensure compliance with company SOPs and specifications, FDA, Eu. Ph., GLP, GDP, QSR, and CGMP regulationsAlways maintain sample tracking and integrity until analyses are reviewedAs 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 recommendationsSupport internal and external lab audits as required, including representing QC to auditors as neededQualificationsBachelor's Degree in Microbiology, Biological Sciences are related scientific disciplineKnowledge of aseptic techniqueProficient in use of computer systems to collect and record dataKnowledge of basic chemical and biological safety proceduresMust 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 knowledgePreferred Qualifications1+ years of Quality and/or lab experienceQuality Control experience in a CGMP manufacturing facility preferredWorking ConditionsLaboratory environment working with chemical reagents and analytical equipmentPersonal Protective Equipment must be worn as requiredEntry into utilities rooms for water samplingClean Room gowning and scrubsNormal office working conditions: computer, phone, files, fax, copierMinimum travel required (Less than 10% domestic)Physical RequirementsParticipation in a holiday and weekend rotation is requiredFrequent lifting up to 25 lbsFrequent standing/walking to work in lab environment for extended periodsFrequent sitting for extended periods to use computerBase Pay Range $XXX,XXX - $XXX,XXXDisclosure Statement Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees' personal and professional wellness. The salary pay range is subject to change and may be modified at any time. Rentschler Biopharma