Microbiology QC Analyst I – CGMP Biopharma Growth

Rentschler Biopharma SE; Milford (MA); On-site; USD 60,000 - 70,000; Full time

Job summary

Rentschler Biopharma SE is seeking a Quality Control Analyst I in Microbiology at our Milford, MA site to perform microbiological analyses on in-process, release, and stability samples. You will support the Microbiology team with testing, compliance, and data integrity in a CGMP environment.

The role requires a Bachelor's degree in Microbiology or related field, aseptic technique, and familiarity with SOPs and regulatory requirements.

Qualifications

• Bachelor’s degree in Microbiology or related sciences.
• Knowledge of aseptic technique and GMP basics.
• Proficient with data capture and record-keeping systems.
• Effective written and verbal communication across teams.

Responsibilities

• Perform microbiological analyses (e.g., Bioburden, Endotoxin, TOC).
• Conduct environmental monitoring of cleanrooms and water sampling.
• Maintain data integrity and comply with SOPs, FDA/CGMP regulations.
• Support internal/external audits and QA inquiries.

Skills

Aseptic technique

Data entry

Written and verbal communication

Education

Bachelor’s Degree in Microbiology

Biological Sciences related discipline

Tools

Computer systems (data capture)

Job description

Rentschler Biopharma SE is seeking a Quality Control Analyst I in Microbiology at our Milford, MA site to perform microbiological analyses on in-process, release, and stability samples. You will support the Microbiology team with testing, compliance, and data integrity in a CGMP environment.

The role requires a Bachelor's degree in Microbiology or related field, aseptic technique, and familiarity with SOPs and regulatory requirements.