Rentschler Biopharma
Quality Control Analyst, Microbiology (2nd Shift - 6+ month contract)
Rentschler Biopharma, Milford, Massachusetts, us, 01757
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 .
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.
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 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
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
Seniority level Associate
Employment type Contract
Job function Quality Assurance, Science, and Manufacturing
Industries Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Rentschler Biopharma by 2x.
Get notified about new Quality Control Analyst jobs in
Milford, MA .
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Rentschler Biopharma .
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.
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 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
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
Seniority level Associate
Employment type Contract
Job function Quality Assurance, Science, and Manufacturing
Industries Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Rentschler Biopharma by 2x.
Get notified about new Quality Control Analyst jobs in
Milford, MA .
#J-18808-Ljbffr