Quality Control Data Reviewer

Rentschler Biopharma•Milford, MA

1d•Onsite

About The Position

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. As part of the Milford site’s Quality Control team, the Data Reviewer is responsible for the cGMP analytical data review and documentation generated during laboratory analysis in the quality control laboratory. Data review may consist of all/some of the following: • Review and approval of QC test analytics; in process, release, stability, validation • Track, organize, prepare QC test results for product release • Review and approval of LIMS test results, labels and stage reports • Revise SOPs, Forms • Train employees on cGMP/GDP 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 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 ability 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 communications 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 Rentschler Biopharma is a 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. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. 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, we pursue one vision together: advancing medicine to save lives. If you are having difficulty applying, get in touch with our recruiting team: [email protected]

Requirements

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

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 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 ability 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 communications 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