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QC Analyst

Employer
Bimeda
Location
Mankato, Minnesota
Salary
DOE

View more

Job Description

Receive and log into the laboratory all samples required for analytical support.

Perform all quality control analytical methods as required to support Production. 

Assist in the transfer of USP methods for all new products that are developed in-house and/or site transferred into the facility.

Perform review of notebooks and raw data for samples analyzed in the laboratory.

Perform out-of-specification investigations and all required documentation per cGMPs and company procedures. 

Support Continuous Improvement program throughout the company.

Operate, troubleshoot, and maintain analytical equipment used in the laboratory, such as HPLC, GC, FTIR, dissolution apparatus, and TOC analyzer.

Interface with FDA compliance officers during facility inspections.

Review and revise procedures as required to ensure compliance.

Review and revise analytical methods.

Accurately document all data in compliance with GMP.

Perform QA lines check as needed during filling and labelling to support Production.

Perform method verification and validation for HPLC, GC, and other tests.

Other tasks as assigned.

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