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Quality Control Scientist I/II/III

Company: Astrix
Location: Vista
Posted on: November 17, 2021

Job Description:

Great opportunity with a world leading biotechnology company!

Title: Quality Control Scientist I/II/III
Location: Vista, CA
Direct Hire

Job Details:
Maintain and perform daily operations of the QC on a daily basis in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects
Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc.
Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor
Implement and maintain GMP procedures such as following SOP's, Standard Testing Procedures (STP's), written procedure and maintaining proper documentation as necessary for Quality Control
Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
Receive, test and release final product peptide manufactured
Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work
Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy
Write standard operating procedures, standard test procedures and other related GMP documentation
Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC and misc.
Wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility. This work may include calibration and validation of these methods
Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release
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

Qualifications:
Bachelor's Degree in Chemistry or related field and 2+ years of QC experience
Years of experience for level II/III; 5+ years
Must be authorized to work in US

Shift: M-F 8am -5pm
$58k for level I
$65-70k for level II
$82K for level III

Keywords: Astrix, Vista , Quality Control Scientist I/II/III, Other , Vista, California

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