Stability Testing QC Analyst II

Rentschler Biopharma SE; Milford (MA); On-site; USD 53,726 - 63,369; Full time

Job summary

Rentschler Biopharma SE's Milford, MA site is seeking a Quality Control Analyst II for Release and Stability Testing to perform cGMP analytical testing on stability samples and data evaluation. You will ensure testing within predefined windows, adhere to GMP and SOPs, and collaborate with QC and cross-functional teams.

The role requires 3+ years in a cGMP analytical lab, strong data interpretation skills, and proficiency with HPLC/UPLC and Empower software.

Qualifications

• Bachelor's Degree in Life Sciences and 3+ years in a cGMP analytical lab environment.
• Ability to perform analytical testing and data analysis per GMP.
• Excellent time management and communication across diverse groups.

Responsibilities

• Perform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documents.
• Create/revise SOPs, Protocols and Reports.
• Support or lead OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions.
• Update and track metrics for trending and reporting; stability and QC analytical data.

Skills

Analytical testing

cGMP

Data interpretation

Communication

Education

Bachelor's Degree in Life Sciences

Tools

HPLC/UPLC/icIEF

Empower chromatography software

Job description

Rentschler Biopharma SE's Milford, MA site is seeking a Quality Control Analyst II for Release and Stability Testing to perform cGMP analytical testing on stability samples and data evaluation. You will ensure testing within predefined windows, adhere to GMP and SOPs, and collaborate with QC and cross-functional teams.

The role requires 3+ years in a cGMP analytical lab, strong data interpretation skills, and proficiency with HPLC/UPLC and Empower software.