Associate II, Plant Quality Assurance (Biotech)

Location: Framingham, United States; on-site

Salary: $90,000–$116,500 per year, plus performance bonus, equity, and benefits.

Company

A biotechnology company developing oncolytic immunotherapies based on its proprietary RPx platform to transform cancer treatment.

What you will do

• Provide on-floor Quality Assurance oversight for drug substance, drug product, and quality control manufacturing and testing activities.
• Conduct quality walkthroughs and inspections to identify compliance concerns and maintain an inspection-ready environment.
• Review and support the timely closure of quality records, including minor deviations.
• Review production batch records, logbooks, laboratory documentation, and quality system documents.
• Provide cGMP, GDP, and quality system guidance to manufacturing and support personnel, escalating risks when needed.
• Support internal and external audits and regulatory inspections while collaborating with cross-functional teams.

Requirements

• BA or BS in a scientific discipline or related field, or an equivalent combination of education and relevant experience.
• 1–4 years of experience in the pharmaceutical, biotechnology, or another regulated industry preferred.
• Experience providing quality support in a GMP manufacturing environment preferred.
• Strong attention to detail, time management, written communication, and verbal communication skills.
• Ability to work collaboratively across multiple departments.

Culture & Benefits

• Purpose-driven work focused on developing cancer therapies and improving patient outcomes.
• Values centered on collaboration, boldness, commitment, and honest communication.
• Medical, dental, and vision insurance with a 401(k) match.
• Flexible time off and paid holidays, including a year-end shutdown.
• Annual performance incentive bonus, new-hire equity, and ongoing performance-based equity.