QA Analyst (Biotech)

Location: York, United States

Company

hirify.global provides sterile injectable formulation, fill-finish, lyophilization, and related contract development and manufacturing services for pharmaceutical and biotechnology products.

What you will do

• Review batch records, logbooks, and other GMP documentation for accuracy, completeness, and compliance.
• Provide QA oversight for sterile manufacturing, aseptic processing, contamination control, and supporting operations.
• Initiate and support deviations, investigations, CAPAs, change controls, root cause analyses, and quality risk assessments.
• Support environmental monitoring, aseptic process simulations, media fills, sterilization, qualification, and validation activities.
• Identify and escalate GMP, product quality, and compliance concerns.
• Collaborate with Manufacturing, QC, Engineering, Validation, Warehouse, and other teams on audits and inspection readiness.

Requirements

• Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, Quality, or a related technical discipline.
• At least 2 years of experience in a GMP-regulated pharmaceutical, biopharmaceutical, biotechnology, or related manufacturing environment.
• Knowledge of GMP requirements, quality systems, batch record review, deviations, investigations, CAPAs, change controls, and quality risk management.
• Familiarity with sterile or aseptic manufacturing, environmental monitoring, APS/media fills, sterilization, and contamination control.
• Strong attention to detail, organizational, written, verbal communication, and cross-functional collaboration skills.

Culture & Benefits

• Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Employee assistance, life insurance, short- and long-term disability, and other insurance options.
• 401(k) plan with matching.
• PTO, sick time, and paid holidays.
• Education assistance, pet insurance, fitness perks, and financial discounts.