Job Summary: We are seeking an experienced QC Analytical Services Specialist to perform various tasks.
Responsibilities:
* Define, schedule, coordinate, and drive to completion of all required sections for Annual Product Quality Review (APQR) reports.
* Define, schedule, coordinate, and drive to completion of all Annual Trend Reports.
* Support harmonization of trending across sites.
* Oversight and management of the Method Performance Monitoring Program, incorporating Reference Standard monitoring and invalid rate tracking.
Requirements:
* Bachelor of Science in Biochemistry or related discipline.
* Minimum 3 years hands-on experience in a GMP Laboratory Setting and QC Trending experience is preferable, preferably Biologics.
* A strong fundamental understanding of protein biochemistry is desirable.
Skills Required:
* HPLC/UPLC
* CE
* cIEF
* SDS-PAGE
* Biacore
* Bioassay
* Compendial techniques (KF, HIAC)