Quality Assurance Associate
AL Solutions
San Diego, CA0–6 yrs6m agovia LinkedIn
This job at a glance
- Who can apply
- New grads and up to 6 years · Bachelor's degree
- Must know
- OperationsAuditingBusiness analysis
- Work
- On-site in San Diego
- Pay
- Not stated by the employer.
- Skill demand
- Auditing66%Operations44%Business analysis20%of 99 similar entry-level jobs posted in the US this week
- Listed
- Nov 11, 2026 · still open
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Job Title: Quality Assurance Associate (QC Associate I / II)
About the Role
We are seeking a detail-oriented laboratory professional with experience in biologics testing and GMP-regulated environments. This is an excellent opportunity to contribute to the development and manufacture of innovative biologics while working within a highly collaborative, quality-focused environment.
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.
Requirements & Tech Stack
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)
Qualifications
- 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.
- 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.