Summary

The Quality Assurance Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of executed procedures, equipment logs, and batch records supporting all aspects of cGMP operations.

Job description

Position Summary

The Quality Assurance Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of executed procedures, equipment logs, and batch records supporting all aspects of cGMP operations.

Position Responsibilities

Perform compliance review on the following executed records: batch and solution record (includes on-the-floor review of records) and associated forms, in-process data, and applicable logs
Author new and revised Standard Operating Procedures, Forms/Logs, Master Batch Records and Solution Records
Support Manufacturing changeover process
Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner
Author, review, and approve deviation investigations
Support client batch record review process
Support QA Raw Material group with release of raw materials as needed
Able to react to change productively and handle other essential tasks as assigned.

Position Requirements

QA Specialist I: Bachelor's degree and 2 years of experience
QA Specialist II: Bachelor's degree and 6 years of experience
Experience in a cGMP QA environment or equivalent is preferred.

Requirements

Bachelor's degree
2 years of experience for QA Specialist I
6 years of experience for QA Specialist II
Experience in a cGMP QA environment or equivalent is preferred
Ability to work night shifts
Collaborate effectively with manufacturing and laboratory departments

Benefits

Shift differential

Company overview

KBI Biopharma is an award-winning global contract development and manufacturing organization (CDMO) that provides fully integrated, accelerated drug development and biologics manufacturing services to pharmaceutical and biotechnology companies worldwide. Founded in 1996 and now part of JSR Life Sciences, KBI has established itself as a next-generation CDMO specializing in complex biologics. The company serves over 500 client partners and has supported the advancement of more than 160 drug candidates from preclinical stages to market, including the manufacture of ten commercial products. KBI's comprehensive service portfolio includes cell line development, process development, analytical services, formulation development, and clinical and commercial cGMP manufacturing for both mammalian and microbial programs. With strategically located facilities across the United States and Europe, KBI leverages world-class analytical capabilities and proprietary platforms like SUREtechnology™ and PUREplatform™ to deliver personalized, accelerated solutions for biopharmaceutical development. The company is recognized for its scientific excellence, quality manufacturing, and commitment to helping clients bring innovative medicines to patients faster.