Temporary - Senior Associate, QC Stability and Reference (Biotechnology)

Location: On-site in Culver City, California, United States

Salary: $35.50–$39.00 per hour, depending on qualifications, experience, and geographic location.

Company

Commercial-stage biotechnology company developing cell and immunotherapy products, next-generation therapies, and vaccines for cancer and infectious diseases.

What you will do

• Coordinate stability and reference activities, including test forecasting, scheduling, data entry, trending, and protocol and report drafting.
• Coordinate, pack, ship, and receive stability and reference materials on site.
• Maintain controlled documents, inventory logs, and other stability and reference records.
• Assist with updates to IND, BLA, and other regulatory submission modules.
• Maintain stability chamber equipment and complete maintenance records.
• Support quality systems by completing change requests and updating SOPs and related documents.

Requirements

• Bachelor’s degree in Biology or a related field.
• 2+ years of experience in a biotechnology quality control testing environment.
• Experience with GMP and knowledge of cGMP, FDA, ICH, and USP regulations.
• Strong organization, attention to detail, communication, interpersonal, and problem-solving skills.
• Working knowledge of Microsoft Word, PowerPoint, and Excel, with a basic understanding of statistics.
• Ability to work on site in a laboratory environment, with occasional off-hours flexibility and the ability to lift and carry up to 20 pounds.

Culture & Benefits

• Collaborative, interactive, and goal-oriented working environment.
• Professional development opportunities within a growing publicly traded biopharmaceutical company.
• Medical, dental, and vision plan options for eligible employees.
• 401(k) retirement plan with company match, flexible spending accounts, wellness programs, and employee assistance program.
• Paid time off, including 11 holidays, with vacation and health-pay provisions for non-exempt employees.