Investigation Specialist I

Location: On premise in Andover, Massachusetts, United States. Candidates must have permanent U.S. work authorization; U.S. work visa sponsorship is not available.

Annual base salary: $60,200–$100,400, plus eligibility for a 7.5% bonus target.

Company

hirify.global develops and manufactures medicines and relies on pharmaceutical manufacturing and quality teams to support patient care.

What you will do

• Lead and author GMP investigations covering manufacturing deviations, product quality excursions, equipment and facility events, and compliance observations.
• Collect and assess manufacturing records, process and laboratory data, audit trails, equipment histories, and enterprise system information.
• Facilitate cross-functional teams to identify root causes using structured problem-solving and quality risk management methods.
• Partner with Manufacturing, Quality Assurance, Process Development, Engineering, Validation, and Analytical teams on event impact, product disposition, and corrective and preventive actions.
• Drive investigations to completion while maintaining quality, regulatory compliance, and established timelines.
• Evaluate investigation trends and support audits, inspections, CAPA effectiveness reviews, risk assessments, and procedure development.

Requirements

• Bachelor’s degree with 0–2 years of relevant experience, or an Associate’s degree with 4 years of relevant experience, or a high school diploma with 6 years of relevant experience.
• Strong technical writing and documentation skills, including the ability to author complex GMP records.
• Experience in a GMP biotechnology manufacturing or laboratory environment.
• Ability to analyze technical data, identify trends, and present clear, evidence-based conclusions.
• Strong organizational and project management skills with the ability to manage multiple priorities and deadlines independently.
• Permanent authorization to work in the United States is required.

Nice to have

• Experience with generative AI tools such as ChatGPT or Microsoft Copilot and responsible AI practices.
• Experience with cGMP investigations, deviations, CAPAs, and quality event records.
• Knowledge of biologics manufacturing, including cell culture, purification, filtration, formulation, and supporting utilities.
• Familiarity with Fishbone, 5-Why, FMEA, Fault Tree Analysis, DeltaV, SAP, LIMS, electronic batch records, and data historian platforms.
• Experience supporting regulatory inspections, internal audits, and inspection readiness.

Culture & Benefits

• On-premise work in a pharmaceutical manufacturing environment, including gowning into and out of manufacturing clean rooms.
• Comprehensive medical, prescription drug, dental, and vision coverage.
• 401(k) plan with hirify.global matching contributions and an additional retirement savings contribution.
• Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
• Relocation assistance may be available based on business needs and eligibility.