Rentschler Biopharma
Quality Control Data Reviewer
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, underscoring 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
Review and approval of cGMP analytical data comparing results to internal and customer specifications, SOPs, and established standards to ensure accuracy and quality of data
Works collaboratively with QC team members and cross‑functional teams for timely resolution of quality issues to achieve project goals
Support Product Release activities ensuring timelines are met
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Identify and resolve issues with assistance from the Data Review team
Review of LIRs
Support all data integrity initiatives and strive for right first time
Make daily decisions about the quality of data based on biochemical knowledge and compliance background
Revise, create SOPs and/or test forms as required
Assists with metrics for trending and reporting as required, stability and QC analytical data
Task and team‑oriented, analytical, organized, detail‑oriented, self‑motivated and able to multitask
Exceptional communication and interpersonal skills
Assists in training of new hires and retraining of QC laboratory staff, as needed
Assist/mentor QC new hires on cGMP/GDP
Strong knowledge of QC analytical equipment and software required
Strong communication skills – written and verbal
Able to prioritize workload to meet stringent timelines
Provide timely status updates to Management upon request
Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
Performs other duties as assigned
Qualifications
B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences
3+ years in a cGMP analytical laboratory environment
HPLC, PA800, CS2500, SDS Page
LIMS, EMPOWER
cGMP experience
Working Conditions
Personal protective equipment must be worn in the laboratories according to Rentschler safety requirements
Will interact with other departments
Pace may be fast and job completion demands may be high
Not a hybrid position, work must be performed on site
Physical Requirements
May be required to stand for long periods of time while performing review of lab logbooks, equipment, lab documentation
Must be able to walk distances between labs, offices, departments
Must be able to work safely in a lab environment
PPE as required
Seniority Level
Associate
Employment Type
Full-time
Job Function
Quality Assurance, Manufacturing, and Analyst
Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr
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, underscoring 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
Review and approval of cGMP analytical data comparing results to internal and customer specifications, SOPs, and established standards to ensure accuracy and quality of data
Works collaboratively with QC team members and cross‑functional teams for timely resolution of quality issues to achieve project goals
Support Product Release activities ensuring timelines are met
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Identify and resolve issues with assistance from the Data Review team
Review of LIRs
Support all data integrity initiatives and strive for right first time
Make daily decisions about the quality of data based on biochemical knowledge and compliance background
Revise, create SOPs and/or test forms as required
Assists with metrics for trending and reporting as required, stability and QC analytical data
Task and team‑oriented, analytical, organized, detail‑oriented, self‑motivated and able to multitask
Exceptional communication and interpersonal skills
Assists in training of new hires and retraining of QC laboratory staff, as needed
Assist/mentor QC new hires on cGMP/GDP
Strong knowledge of QC analytical equipment and software required
Strong communication skills – written and verbal
Able to prioritize workload to meet stringent timelines
Provide timely status updates to Management upon request
Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
Performs other duties as assigned
Qualifications
B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences
3+ years in a cGMP analytical laboratory environment
HPLC, PA800, CS2500, SDS Page
LIMS, EMPOWER
cGMP experience
Working Conditions
Personal protective equipment must be worn in the laboratories according to Rentschler safety requirements
Will interact with other departments
Pace may be fast and job completion demands may be high
Not a hybrid position, work must be performed on site
Physical Requirements
May be required to stand for long periods of time while performing review of lab logbooks, equipment, lab documentation
Must be able to walk distances between labs, offices, departments
Must be able to work safely in a lab environment
PPE as required
Seniority Level
Associate
Employment Type
Full-time
Job Function
Quality Assurance, Manufacturing, and Analyst
Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr