Quality Control Data Reviewer

Job Overview

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects, offering customized full‑service solutions for bioprocess development and the production of complex biopharmaceuticals. The role is located at the Milford site in the United States as part of the Quality Control team.

• Review and approve QC test analytics (in process, release, stability, validation)
• Track, organize, and prepare QC test results for product release
• Review and approve LIMS test results, labels and stage reports
• Revise SOPs and forms
• Train employees on cGMP/GDP duties and responsibilities
• Review cGMP analytical data comparing results to internal and customer specifications, SOPs and established standards to ensure accuracy and quality of data
• Work collaboratively with QC team members and cross‑functional teams to resolve quality issues promptly and achieve project goals
• Support product release activities to ensure timely release of products
• Analyze data to identify trends and issues, providing root‑cause analysis and resolution plans
• Support LIR reviews and data integrity initiatives
• Make daily decisions about data quality based on biochemical knowledge and compliance background
• Create or revise SOPs and test forms as required
• Assist with metrics for trending and reporting of stability and QC analytical data
• Mentor and train new hires and retrain QC laboratory staff as needed
• Maintain a task‑oriented, analytical, organized, detail‑oriented and self‑motivated work approach in a multitasking environment

• B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences
• Minimum 3years of experience in a cGMP analytical laboratory environment
• Experience with HPLC, PA800, CS2500, SDSPage instruments
• Experience with LIMS and EMPOWER cGMP systems
• Strong knowledge of QC analytical equipment and software
• Strong written and verbal communication skills
• Ability to prioritize workload to meet stringent timelines
• Proficiency with MS Outlook, Word, Excel, PowerPoint, and other electronic systems

• Personal protective equipment must be worn in the laboratories according to Rentschler safety requirements
• Interaction with other departments; fast pace with high demands for job completion
• Position requires on‑site work; not a hybrid role

• Must be able to stand for long periods while reviewing lab logbooks, equipment, and documentation
• Must be able to walk distances between labs, offices, and departments
• Must be able to work safely in a laboratory environment with appropriate PPE

Base Pay Range: $90,000 - $110,000

Disclosure Statement:
Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably and in good faith expects to pay for this position at this time.