Quality Assurance Associate

QC Associate I / II (Contract)

Quality Control | Biologics | GMP Environment

Are you a detail-oriented laboratory professional with experience in biologics testing and GMP-regulated environments? We are seeking a QC Associate I or II to join a growing Quality Control team, supporting analytical testing, method transfers, validation activities, and release testing for biologic products.

This is an excellent opportunity to contribute to the development and manufacture of innovative biologics while working within a highly collaborative, quality-focused environment.

The Opportunity

As a QC Associate I / II, you will perform analytical testing and laboratory activities supporting stability programs, method qualifications, validations, and product release testing. You will play a key role in maintaining compliance with cGMP, GDP, ALCOA+ data integrity principles, and global regulatory standards while ensuring laboratory inspection readiness.

Working closely with Quality Assurance, Analytical Development, Manufacturing, MSAT, and other cross-functional teams, you will help drive quality, compliance, and operational excellence across QC operations.

Role overview

Employment type: Contract

Length: 6-months with a view to extend or go permanent

Hours: Full-time

Working model: On-site in San Diego

Payment options: W2 or 1099

Key Responsibilities

Analytical Testing & Laboratory Operations

• Perform routine and non-routine testing of:
• In-process samples
• Release samples
• Stability samples
• Raw materials
• Reference standards
• Investigational materials
• Execute analytical methods for biologics and large molecule products using:
• HPLC/UHPLC
• CE-SDS
• cIEF/icIEF
• ELISA
• UV-Vis Spectroscopy
• Compendial methods
• Additional biochemical and physicochemical techniques
• Complete testing accurately and within established timelines.
• Maintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and data integrity requirements.
• Support method transfer, method qualification, verification, and validation activities.

Data Review & Documentation

• Perform first-person review of analytical data.
• Prepare and review:
• Certificates of Analysis (CoA)
• Stability Summary Sheets (SSS)
• Analytical reports
• Method qualification reports
• Validation reports
• Technical documentation
• Ensure all documentation remains complete, attributable, contemporaneous, and inspection-ready.

Compliance & Continuous Improvement

• Participate in laboratory investigations including:
• OOS (Out of Specification)
• OOT (Out of Trend)
• Invalid result investigations
• Support internal audits, client audits, and regulatory inspections.
• Assist with equipment maintenance and qualification activities.
• Contribute to process improvement initiatives and implementation of new technologies.
• Identify and escalate compliance or data integrity concerns.

What We're Looking For

Education

• Bachelor's degree in:
• Biology
• Biochemistry
• Chemistry
• Biotechnology
• Pharmaceutical Sciences
• Or a related scientific discipline

Experience

QC Associate I

• 0-3 years of laboratory experience within biotechnology, pharmaceutical, or related industries.

QC Associate II

• 3-6+ years of experience in a GMP-regulated Quality Control laboratory environment.

Technical Skills

Experience with one or more of the following is highly desirable:

• HPLC/UHPLC
• CE-SDS
• ELISA
• cIEF/icIEF
• UV-Vis
• Stability testing
• GMP documentation
• Method transfer and validation
• Data integrity and ALCOA+ principles
• LIMS systems (preferred)

Ideal Candidate

You are:

• Highly organized and detail-oriented
• Passionate about quality and compliance
• Comfortable working in a fast-paced GMP environment
• Experienced in biologics or large-molecule analytical testing
• A collaborative team player with strong communication skills
• Committed to maintaining inspection readiness and data integrity

Physical Requirements

• Ability to stand and walk for extended periods.
• Frequently lift and/or move objects up to 20 lbs.
• Ability to use hands and arms for laboratory activities.
• Ability to bend, kneel, crouch, balance, and reach as required.
• Strong visual acuity, including color vision and depth perception.