Deviations Investigator II (Biotech)

Location: Portsmouth, New Hampshire, United States; on-site. Monday–Friday, 8:00 a.m.–4:30 p.m.

Company

hirify.global operates life-science manufacturing sites worldwide and supports the development and production of medicines and therapies.

What you will do

• Independently lead and complete minor deviation investigations.
• Support major deviation investigations under team leadership guidance.
• Apply root cause analysis tools, including 5 Whys, fishbone analysis, and cause mapping.
• Make real-time decisions about deviation containment and investigative approaches.
• Develop and implement CAPAs, manage concurrent investigations, and drive documentation quality toward more than 80% Right First Time.
• Mentor Level I investigators and collaborate cross-functionally to resolve issues and maintain investigation quality.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field, plus 3–5+ years of experience in a GMP-regulated environment, preferably Quality Assurance.
• Strong knowledge of cGMP, Good Documentation Practices, and data integrity principles.
• Experience leading deviation investigations, performing root cause analysis, and developing CAPAs.
• Ability to manage multiple priorities, make sound decisions, and meet deadlines in a fast-paced environment.
• Strong technical writing, attention to detail, communication, collaboration, and mentoring skills.
• Proficiency in Microsoft Office, including Excel, Word, and PowerPoint.

Nice to have

• Experience with biologics or mammalian processes.

Culture & Benefits

• Agile, collaborative, inclusive, and ethical working environment.
• Medical, dental, and vision insurance.
• Performance-recognizing compensation programs.
• Career growth and development opportunities.
• Opportunity to support the delivery of life-changing therapies.