Senior QA Specialist/Principal Specialist Client Support (Pharmaceutical)

Location: Boulder, Colorado, United States

Salary: Senior: $90,000–$115,000 per year; Principal: $100,00–$130,000 per year

Company

hirify.global provides biopharmaceutical development and manufacturing services across a global network.

What you will do

• Act as the quality liaison between KBI and clients on batch status, quality metrics, quality issues, and disposition timelines.
• Facilitate resolution of client concerns, communicate with internal teams, and escalate issues when needed.
• Lead QA support for projects as the accountable quality lead, decision maker, and delegate.
• Support product release processes, including deviation investigations, CAPA reviews and approvals, and complaint activities.
• Support audit and inspection readiness, participate in regulatory and quality report-outs, and represent KBI during client-facing audits and meetings.
• Compile, analyze, and report quality and client metrics, including completing Annual Product Quality Reviews for commercial programs.

Requirements

• BS/BA degree in science or engineering relevant to pharmaceutical, life science, or related industries; an AS/AA degree may be accepted with additional relevant experience.
• Principal level: 5+ years in the pharmaceutical or biotechnology industry, including 7–10 years of relevant experience for the degree-equivalent pathway.
• Senior level: 3+ years in the pharmaceutical or biotechnology industry, including 5–7 years of relevant experience for the degree-equivalent pathway.
• At least 2 years of QA experience and prior client-facing QA experience.
• Thorough knowledge of quality systems, quality assurance, quality control, and global GMP and regulatory requirements.
• On-site role based in Boulder, Colorado, United States.

Nice to have

• Project management experience or formal project management training.

Culture & Benefits

• Full-time employment.
• Interaction with functions across a global company network.
• Equal opportunity and affirmative action employment environment.