QC Associate/Sr. QC Associate
Valentia Analytical is seeking a QC Associate/Sr. QC Associate to join our CGMP Quality Analytical Team in Fremont, CA to be primarily responsible for ELISA and Bioassay testing. This associate would support other techniques including UHPLC, CIEF, CESDS, GC-MS, and physico-chemical. This is a uniquely exciting opportunity for those without direct experience to gain such across a multitude of assays and sample types including proteins, small molecules, and gene therapeutic products. This is a quality-focused company offering elite analytical support to clients of the biotechnological, pharmaceutical, and gene-therapeutic industries. The company is committed to strong systems. This commitment enabled the company to achieve ISO17025:2017 accreditation by the ANSI National Accreditation Board in its first year of operation and has maintained it since. We specifically seek individuals looking to be part of culture fostering quality, clean work, and a positive team supporting environment.
- Develop/transfer, validate, perform, and maintain analytical assays primarily for ELISA and Bioassay to characterize biomolecules for potency.
- Support development, transfer, validation, and/or testing other analytical assays and equipment including UHPLC/HPLC, Gas Chromatography (GC-MS), CE (CIEF/CE-SDS), and physico-chemical assays (UV using SoloVPE, Karl Fischer Titration, appearance, and subvisible particles).
- Author technical documents including test methods, equipment procedures, development reports, validation protocols/reports, and/or investigation reports.
- Execute analytical methods validations in accordance with ICH Q2.
- Maintain compliance CGMP and laboratory systems such as those managing samples, reagents, equipment, and documentation.
- Enforce FDA regulatory requirements including 21CFR11, 21CFR210, 21CFR211
Summary of Qualifications
- Bachelor’s or master’s degree in Chemistry, Biology, Biochemistry or other related field,
- Preferably 3-5 years laboratory experience performing ELISA and/or Bioassay within a GMP environment testing proteins and/or antibody-drug conjugates.
- The candidate will be capable of learning new skills and multi-tasking independently.
- The candidate should be able to work and troubleshoot independently in a CGMP compliant environment.