QC Analyst 3

ProKidney•Winston Salem, NC

33d

About The Position

The Quality Control Analyst position involves performing various testing activities to support the Quality Control department, including bio-analytical testing, raw material testing, and protocol testing. The role requires maintaining quality systems and data generated by team members, contributing to investigations, and ensuring compliance with industry standards

Requirements

Minimum of Bachelor's Degree (or better) in chemistry, biochemistry, microbiology or related science
3-5 years' experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry
Knowledge of cGMP and understanding of GxP, good clinical practices, and FDA guidelines
Familiarity with bioassays, and raw material test methods
Knowledge of LIMS systems
Deviation Handling
Change Control Management
OOS Investigation experience
Subject Matter Expertise in assays relevant to the QC Labs
Strong communication skills with the ability to interact with various individuals
Detail-oriented with problem-solving and decision-making abilities

Responsibilities

Performs routine Bioanalytical testing and release of in-process, stability and REACT Final Product samples as scheduled
Executes routine and non-routine analysis, including but not limited to raw materials, in-process items and finished product according to established operating procedures; may include: Flow Cytometry ELISA Kinetic Assays Cell Counting/Viability Visual Appearance
Initiates and Supports Deviation/OOS investigations in MasterControl
Initiates and Supports Action Item completion as assigned in MasterControl
Initiates and Supports AQEM activities as assigned in Master Control
Follows Test Methods (TSMs) Standard Operating Procedures (SOPs), Work Instructions (WRKs), and Protocols
Authors originals, revisions, and training on TSMs, SOPs, WRKs, Test Forms, and Protocols
Support QC Analytics with sample receipt from Manufacturing
Trains and mentors incoming QC Analysts (all levels)
Track and trend all QC Analytical testing performance of patient lot data along with critical reagent trending
Maintain inventory levels in QC labs and coordinate material requests with Warehouse/Supply Chain
Initiates, and participates in Change Control (MOC) management
Authors/Initiates Aborted/Invalidated Assays in the QC Analytical Lab.
Complete documentation accurately and in a timely manner
Partakes in special projects on analytical methods and instrumentation problems related to execution of assays.
Other duties as assigned