QC Analyst 3

Role Summary

QC Analyst 3 responsible for performing various testing activities to support the Quality Control department, including bio-analytical testing, raw material testing, and protocol testing. Maintains quality systems and data, contributes to investigations, and ensures compliance with industry standards.

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

Qualifications

• Minimum of Bachelor‚Äôs Degree (or better) in chemistry, biochemistry, microbiology or related science
• 3-5 years‚Äô 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