QC Associate I - Contract in San Diego, California at Abzena Inc.

Essential Duties and Responsibilities

Analytical Testing and Laboratory Operations

• Perform routine and non-routine analytical testing of in-process, release, stability, raw material, and investigational samples using approved methods and procedures.
• Execute a variety of analytical techniques commonly used for biologics and large-molecule products, including but not limited to:
  • CE-SDS
  • Endotoxin
  • Raw Material Testing
  • ELISA
  • UV-Vis Spectroscopy
  • Compendial testing
  • Other biochemical and physicochemical methods as applicable.
• Ensure all testing activities are completed accurately, efficiently, and within established timelines.
• Maintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and ALCOA+ data integrity principles.
• Ensure all activities comply with GMP, ALCOA+ principles, and data integrity regulations (FDA, EMA, ICH guidelines).

Other Lab Responsibilities/Skills

• Participate in lifecycle management activities including GMP document management, sample storage/inventory management, and materials ordering.
• Perform first-person review of analytical data to ensure completeness, accuracy, and compliance with applicable procedures and regulatory requirements.
• Ensure documentation is complete, contemporaneous, attributable, and inspection ready.
• Maintain laboratory equipment records and ensure equipment remains in a qualified state.
• Support laboratory readiness for internal audits, client audits, regulatory inspections, and quality assessments.
• Participate in process improvement initiatives to enhance laboratory efficiency, compliance, and data integrity.
• Collaborate effectively with cross-functional teams including QA, Manufacturing, and Materials Management.
• Support implementation of new technologies, systems, and laboratory processes readiness activities.

• Stand/walk during entire length of shift.
• Use of arms, hands and fingers to handle, feel or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus.
• Environment: GMP-regulated Quality Control laboratory.
• Chemical Exposure: Frequent handling of organic solvents, acids, buffers, and standards (e.g., methanol, acetone, IPA, acetonitrile).
• Hazard Exposure: Potential contact with materials classified as corrosive, flammable, toxic, carcinogenic, or reproductive hazards (e.g., boric acid, β-mercaptoethanol, sulfuric acid, silver nitrate).
• Safety Protocols: Strict adherence to the Chemical Hygiene Plan, SOPs, and Safety Data Sheet (SDS) instructions is required.
• PPE Requirements: Mandatory use of lab coats, nitrile gloves, and safety glasses. Tasks may require face shields, splash goggles, or respiratory protection.
• Daily Activities: Frequent pipetting, weighing, reagent preparation, and instrument operation. Handling of hazardous materials occurs inside laboratory hoods.
• Physical Effort: Regular sitting, standing, walking, bending, reaching, and repetitive hand movements.
• Lifting: Ability to occasionally lift and transport laboratory supplies up to 25 pounds.