QC Operations Specialist II

TriLink BioTechnologies•San Diego, CA

7h•Onsite

About The Position

Maravai LifeSciences is seeking a #MiracleMaker to join their Quality Control team as a QC Operations Specialist II. This role involves providing testing and technical oversight in Method Development, Qualification, Validation/Verification of QC test methods related to incoming raw materials, in-process materials, and final manufactured products. The successful candidate will thrive in a flexible fast-paced environment and demonstrate excellent attention to detail.

Requirements

B.S. or advanced degree in chemistry or biology or a related science or a minimum of 6-7 years of experience working in a laboratory, manufacturing, or quality role within the life science industry.
Hands on experience with multiple of the following instrumentation: HPLC, Mass Spec, GC, qPCR, UV-Vis spectrophotometer, Fragment Analyzer, TOC Analyzer, Endotoxin Analyzer, Viable and Non-Viable Air samplers.
Hands on experience in executing Method Development/Qualification/Validation/Verification activities.
Familiar with USP<1225> Validation of Compendial Procedures and/or ICH Q2(R2) Validation of Analytical Procedures.
Familiar with Chromatography Data Systems (i.e. Chromeleon).
Computer skills (Database software, Microsoft Office Suite).
Strong knowledge of and experience using GLP or cGMP principles.
Working knowledge of standard chemical safety/hygiene requirements and overall safe workplace practices, especially in a laboratory setting.
Ability to work independently with little to no supervision.
Strong verbal and written communication skills.
Strong interpersonal skills.
Strong problem solving, observation skills, and attention to detail.
Self-motivated and able to organize and prioritize multiple tasks.

Responsibilities

Routinely operate analytical (U)HPLC, mass spectrometer, Gas Chromatography, pH/conductivity meter, TOC Analyzer, Viable and Non-Viable Air sampler, qPCR, dot blot, UV-vis spectrometer, FTIR, Fragment Analyzer, and restriction digests.
Generates and executes method qualification/validation protocols.
Troubleshoots routine equipment issues within the laboratory.
Is a technical subject matter expert on a variety of analytical instrumentation (i.e. UHPLC, mass spectrometer, pH/conductivity meter, qPCR, dot blot, UV-vis spectrometer, FTIR, Fragment Analyzer, TOC, EndoToxin Analyzer).
Ensures that all product specifications are met and follows proper procedures for out-of-specification (OOS) results and reporting of non-conforming materials.
Conducts investigations and provides first tier analysis of complaints and non-conforming products.
Primary peer reviewer of testing data and write-ups of other technicians for accuracy and completeness.
Serves as lead QC contact for communication to manufacturing and order fulfillment regarding testing schedule and product readiness.
Trains and develops new team members on test methods.
Serves as delegate for QC Management.
Maintains meticulous documentation of all Quality Control records.
Creation of QC standard operating procedures and optimizing new/existing analytical test methods.
Assists with instrument calibrations and preventative maintenance.
Maintains lab housekeeping, organization, and inventory supply.
Performs other functions and duties as required.