QC Microbiology Specialist I - Bioburden, Endotoxin & TOC

Pfizer; Andover (MA); On-site; USD 60,000 - 100,000; Full time

Job summary

Pfizer is seeking a motivated candidate for the Quality Control Microbiology group to perform bioburden, endotoxin, TOC testing on water and raw material samples, with occasional process samples. The role includes data review, SOP revisions, and document authoring in a GMP environment.

The successful candidate will contribute to QA activities, attend QCM meetings, and ensure testing compliance. On-premise work with opportunities to impact product quality and patient safety.

Qualifications

• Bachelor's degree with 0+ years experience, or an associate's degree with 4 years experience, or a high school diploma and 6 years of relevant experience.
• Knowledge and practical application of relevant techniques – classic microbiology techniques as well as rapid microbial techniques, desired.
• Knowledge of GMP compliance requirements for Quality Control Laboratories.
• Experience with LWLIMS, QTS and PDOCs is a plus.

Responsibilities

• Perform bioburden, endotoxin, conductivity and TOC assays.
• Collect EM/water samples (monitoring) and associated testing.
• Ensure all aspects of testing are performed per GMP and SOPs.
• Review GMP data, reports, procedures.
• Author reports and/or SOP revisions as needed.
• Attend QCM at meetings and huddles

Skills

Bioburden testing

Endotoxin testing

TOC testing

GMP compliance

Classic microbiology techniques

Education

Bachelor's degree

Associate's degree

High school diploma

Tools

LWLIMS

QTS

PDOCs

Job description

Pfizer is seeking a motivated candidate for the Quality Control Microbiology group to perform bioburden, endotoxin, TOC testing on water and raw material samples, with occasional process samples. The role includes data review, SOP revisions, and document authoring in a GMP environment.

The successful candidate will contribute to QA activities, attend QCM meetings, and ensure testing compliance. On-premise work with opportunities to impact product quality and patient safety.