Rentschler Biopharma
Quality Control Analyst II, Microbiology
Rentschler Biopharma, Milford, Massachusetts, us, 01757
Overview
Quality Control Analyst II, Microbiology at
Rentschler Biopharma Advance medicine to save lives. Join our team to contribute 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 production of complex biopharmaceuticals. As a German family-owned company with an international footprint, 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. Our motto is: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. We pursue one vision together: advancing medicine to save lives.
Duties And Responsibilities
In accordance with test method SOPs, 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 or 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.
Ability 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 in lab environment for extended periods.
Frequent sitting for extended periods to use computer.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance, Manufacturing, and Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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Quality Control Analyst II, Microbiology at
Rentschler Biopharma Advance medicine to save lives. Join our team to contribute 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 production of complex biopharmaceuticals. As a German family-owned company with an international footprint, 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. Our motto is: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. We pursue one vision together: advancing medicine to save lives.
Duties And Responsibilities
In accordance with test method SOPs, 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 or 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.
Ability 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 in lab environment for extended periods.
Frequent sitting for extended periods to use computer.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance, Manufacturing, and Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr