QC Associate I - Contract

Abzena•San Diego, CA

10d

About The Position

The QC Associate I performs analytical testing and laboratory activities supporting stability, qualification/validation, and release testing of biologics in a cGMP-regulated environment. The role supports routine QC operations through analytical method execution, data review, equipment maintenance, QC inventory management, and continuous improvement while ensuring compliance with cGMP, Good Documentation Practices (GDP), and applicable regulatory requirements. The successful candidate demonstrates technical expertise, attention to detail, data integrity awareness, and a commitment to inspection readiness while supporting internal and client-driven programs. The position is based in a GMP-regulated Quality Control laboratory. Work includes frequent pipetting, weighing, reagent preparation, and instrument operation, as well as handling hazardous materials inside laboratory hoods. Chemical exposure includes frequent handling of organic solvents, acids, buffers, and standards. Strict adherence to the Chemical Hygiene Plan, SOPs, and Safety Data Sheet instructions is required, along with mandatory use of lab coats, nitrile gloves, and safety glasses. Some tasks may require face shields, splash goggles, or respiratory protection. Essential functions can be performed with or without reasonable accommodation.

Requirements

Bachelor’s degree in biology, biochemistry, chemistry, pharmaceutical sciences, biotechnology, or a related scientific discipline.
0–2 years of laboratory experience in biotechnology, pharmaceutical, or related industries.
Ability to stand and walk during the entire shift.
Use arms, hands, and fingers to handle, feel, or reach.
Ability to climb, balance, stoop, kneel, crouch, or crawl.
Near and far vision, color and peripheral vision, depth perception, and ability to focus.
Ability to occasionally lift and transport laboratory supplies weighing up to 25 pounds.
Adhere strictly to the Chemical Hygiene Plan, SOPs, and Safety Data Sheet instructions.
Use required PPE, including lab coats, nitrile gloves, and safety glasses; some tasks may require face shields, splash goggles, or respiratory protection.

Responsibilities

Perform routine and non-routine analytical testing of in-process, release, stability, raw material, and investigational samples using approved methods and procedures.
Use analytical techniques for biologics and large-molecule products, including CE-SDS, endotoxin testing, raw material testing, ELISA, UV-Vis spectroscopy, compendial testing, and other applicable biochemical and physicochemical methods.
Complete testing accurately, efficiently, and within established timelines.
Maintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and ALCOA+ data integrity principles.
Ensure activities comply with GMP, data integrity principles, and applicable FDA, EMA, and ICH requirements.
Participate in lifecycle management activities, including GMP document management, sample storage and inventory management, and materials ordering.
Perform first-person review of analytical data for completeness, accuracy, and compliance with procedures and regulatory requirements.
Maintain complete, contemporaneous, attributable, and inspection-ready documentation.
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 with QA, Manufacturing, and Materials Management.
Support readiness activities for implementation of new technologies, systems, and laboratory processes.
Follow laboratory safety requirements, including applicable PPE and safe handling procedures for hazardous materials.