Quality Assurance Specialist - 2nd Shift (3pm - 11:30pm) (Biotech)

Location: On-site in Easton, Pennsylvania, United States; second shift from 3:00 p.m. to 11:30 p.m.

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead second-shift sampling and inspection of incoming raw materials for the Raw Material Center warehouse.
• Review receiving, storage, and distribution documentation and approve raw-material lot disposition.
• Provide operational oversight to ensure compliance with safety, GMP, GDP, and Good Documentation Practices.
• Manage quality oversight of logistics and transportation service providers, including service levels, metrics, and improvement plans.
• Advise operational and cross-functional teams on quality matters, risk management, deviations, change controls, and CAPAs.
• Represent the Quality Unit during internal and external audits, regulatory inspections, and inspection-readiness activities.

Requirements

• Doctorate degree; or master's degree plus 2 years of quality assurance experience; bachelor's degree plus 4 years; associate degree plus 8 years; or high school diploma/GED plus 10 years.
• Experience with raw-material incoming sampling and inspection, distribution, warehousing, manufacturing, validation, or engineering functions.
• Knowledge of GMP, GDP, import/export requirements, and quality systems, including deviations, change controls, and CAPAs.
• Experience with Veeva, SM LIMS, ERP systems, Microsoft 365, and Power Platform.
• Ability to lead, train, mentor, and communicate effectively with cross-functional teams and external providers.
• Strong critical thinking, problem-solving, scientific decision-making, and regulatory-inspection skills.

Nice to have

• Academic background in life sciences, physical sciences, applied engineering, or manufacturing technologies.
• Experience using AI tools and digitalization in daily work.
• Skills in continuous improvement and process optimization.

Culture & Benefits

• Employee health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Collaborative, innovative, science-based work environment focused on patient impact.