QA Project Leader (Microbiology Sterility Assurance)

Location: Melrose Park, Illinois, United States

Salary: $90,000–$110,000 per year

Company

hirify.global operates in a regulated pharmaceutical manufacturing environment focused on quality, compliance, and product release.

What you will do

• Manage compliance and continuous improvement projects across QA and operations.
• Track project plans, deliverables, deadlines, responsibilities, risks, and corrective actions.
• Drive improvements in deviation reduction, batch right-first-time performance, batch release cycle time, yields, rejects, complaints, and CAPA execution.
• Analyze quality and manufacturing data, consolidate metrics, and recommend process improvements.
• Review root-cause analyses, investigations, corrective and preventive actions, and effectiveness measures.
• Support FDA and regulatory inspections, prepare senior-management progress reports, and coordinate responses to emerging issues.

Requirements

• Bachelor’s degree in science and at least 3 years of progressive QA/QC experience in pharmaceutical or related regulated industries.
• Advanced training or experience in cGMP and preferably GLP, legal, and ISO requirements.
• Strong technical experience in microbiology and aseptic processing in pharmaceutical manufacturing.
• Experience creating and managing Contamination Control Strategies and authoring or reviewing SOPs, work instructions, and FMEA-based risk assessments.
• Familiarity with Aseptic Process Simulations, media fills, aseptic drug-product manufacturing, and isolator technology.
• Effective spoken and written English is required for regulated workplace communication, policies, procedures, and training materials.

Nice to have

• Experience providing technical leadership from a microbiology and sterility-assurance perspective.
• Experience leading cross-functional meetings and supporting regulatory or FDA inspections.

Culture & Benefits

• Full-time employment with an at-will employment arrangement.
• Medical, prescription drug, dental, and vision coverage.
• 401(k) plan with company contributions.
• Paid vacation, holidays, and personal days.
• Employee assistance, life insurance, disability coverage, and wellness programs.