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QC Manager
Carlsbad, CA
Date Posted
01/20/2009
Employment Type
Direct Hire
Job ID
6309
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Quality Control Manager
BASIC OBJECTIVE:
This function is to oversee laboratory day-today operations, guide and interact with QC and department personnel to accomplish goals and objectives as directed by supervisor. Other duties include performing raw material testing, final product testing, QC documentation and related GMP activities.
SPECIFIC DUTIES AND RESPONSIBILITIES:
- Maintain and coordinate the operation of the QC on a daily basis in coordination with the QC Director to include testing of raw material/peptide samples and prioritizing projects.
- Oversee control raw material used in the manufacturing facility for GMP to include receiving, testing, quarantine and release.
- Receive, test and release final product.
- Writing any specifications if necessary, performing analytical analysis and reviewing data for completeness and accuracy.
- Write standard operating procedures, standard test procedures and other related GMP documentation as necessary.
- Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control.
- Operate, maintain and ensure calibration of equipment including GC, HPLC, Karl-fisher, Melting point apparatus, Mass Spec, analytical balance, UV spectrophotometer, pipette and other related analytical equipment used for control quality of the GMP facility.
- Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor.
- Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility.
- Write CMC quality section as needed for customers
- Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals.
QUALIFICATIONS:
A minimum of college level degree (bachelors or higher in a scientific field) and a minimum of 6 years of experience in a GMP or job related environment.
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