Associate II, Plant Quality Assurance

Summary of Job Description

The Associate II, Plant Quality Assurance (PQA) reports to the Manager, Plant Quality Assurance and is responsible for providing day-to-day Quality oversight to support Drug Substance, Drug Product, and Quality Control operations in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulatory requirements. This position works closely with Manufacturing, Quality Control, and other cross-functional teams to support compliance initiatives, batch record review, quality record review, and maintenance of a quality-focused culture. The Associate II will provide oversight of manufacturing floor activities and will provide quality guidance or escalate problems in real-time to ensure activities are performed in compliance with established procedures and regulatory expectations.

Key Responsibilities

• Provide on-floor Quality Assurance support to help ensure manufacturing and testing activities are performed in compliance with cGMP requirements and approved procedures
• Perform quality walkthroughs and inspections to promote an inspection-ready environment and identify potential compliance concerns
• Support the review and timely closure of quality records, including minor deviations
• Review production batch records, logbooks, and laboratory documentation for accuracy, completeness, and compliance with established procedures
• Assist in authoring, revising, and reviewing quality system documents, including standard operating procedures
• Provide guidance and support to manufacturing and support personnel regarding cGMP, GDP, and quality system requirements
• Escalate quality issues and compliance risks to management as appropriate

Other Responsibilities

• Support internal and external audits and regulatory inspections as required
• Collaborate effectively with cross-functional teams to promote quality and compliance objectives
• Perform other duties as assigned

Educational Requirements

BA or BS degree in a scientific discipline or related field, or equivalent combination of education and relevant experience.

Experience and Skill Requirements

• 1-4 years of experience in the pharmaceutical, biotechnology, or related regulated industry preferred
• High level of attention to detail and excellent time management
• Strong written and verbal communication skills
• Demonstrated ability to work collaboratively across multiple departments
• Experience providing quality support within a GMP manufacturing environment preferred

Salary Range

For this role, the anticipated base pay range is $90,000-116,500. The exact base pay offered will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience, as well as current organizational needs. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.

Benefits

• Medical, dental, and vision insurance
• 401k match
• Flexible time off
• Paid holidays including year-end shutdown