Rentschler Biopharma
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Quality Control Analyst II
role at
Rentschler Biopharma
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
Perform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documents
Experience with plate‑based assays e.g., ELISA, potency assays, and qPCR
Create/revise SOPs, Protocols and Reports
Practice safe work habits and adhere to safety procedures and guidelines
Perform maintenance and cleaning of laboratory equipment
SME to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non‑conformances
Update and track metrics for trending and reporting; stability and QC analytical data
Task and team‑oriented, analytical, organized, detail‑oriented, self‑motivated and ability to multitask
Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
Exceptional communication and interpersonal skills
Assists in training of new hires and retraining of QC laboratory staff, as needed
Performs other duties as assigned
Qualifications
Bachelor's Degree in Life Sciences discipline
Minimum 3+ years’ experience in a cGMP analytical lab environment
Must have the ability and skill to perform the detailed job requirements competently, safely, accurately, and proficiently
Self‑starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skills
Able to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable manner
Able to use and learn standard office equipment and technology with proficiency
Experience in Empower chromatography software
Working Conditions
Laboratory environment working with chemical reagents and analytical equipment
Normal office working conditions: computer, phone, files, fax, copier.
Personal Protective Equipment must be worn as required
Work is to be performed on site
Possible weekend/off hours testing may be required
Physical Requirements
Frequent standing/walking
PPE as required
Able to work upright and stationary and/or standing for typical working hours
Able to lift and move objects up to 25 pounds
Seniority level
Associate
Employment type
Full‑time
Job function
Quality Assurance, Manufacturing, and Science
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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Quality Control Analyst II
role at
Rentschler Biopharma
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
Perform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documents
Experience with plate‑based assays e.g., ELISA, potency assays, and qPCR
Create/revise SOPs, Protocols and Reports
Practice safe work habits and adhere to safety procedures and guidelines
Perform maintenance and cleaning of laboratory equipment
SME to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non‑conformances
Update and track metrics for trending and reporting; stability and QC analytical data
Task and team‑oriented, analytical, organized, detail‑oriented, self‑motivated and ability to multitask
Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
Exceptional communication and interpersonal skills
Assists in training of new hires and retraining of QC laboratory staff, as needed
Performs other duties as assigned
Qualifications
Bachelor's Degree in Life Sciences discipline
Minimum 3+ years’ experience in a cGMP analytical lab environment
Must have the ability and skill to perform the detailed job requirements competently, safely, accurately, and proficiently
Self‑starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skills
Able to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable manner
Able to use and learn standard office equipment and technology with proficiency
Experience in Empower chromatography software
Working Conditions
Laboratory environment working with chemical reagents and analytical equipment
Normal office working conditions: computer, phone, files, fax, copier.
Personal Protective Equipment must be worn as required
Work is to be performed on site
Possible weekend/off hours testing may be required
Physical Requirements
Frequent standing/walking
PPE as required
Able to work upright and stationary and/or standing for typical working hours
Able to lift and move objects up to 25 pounds
Seniority level
Associate
Employment type
Full‑time
Job function
Quality Assurance, Manufacturing, and Science
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