QO DP Tech III (Pharmaceutical Quality Assurance)

Location: On premise in Kalamazoo, Michigan, United States. Flexible working hours on the first shift; occasional time in the production environment.

Salary: $23.64–$39.39 per hour, with potential overtime, weekend, holiday, and other pay premiums.

Company

hirify.global develops and manufactures pharmaceutical products with a focus on quality, compliance, and patient safety.

What you will do

• Review and approve clinical and commercial manufacturing and packaging batch records for completeness, accuracy, and compliance with hirify.global policies and cGMP requirements.
• Create, review, and approve GMP audit reports and support inspection readiness, regulatory inspections, and customer audits.
• Provide independent real-time quality impact assessments and decisions for product and medical device issues.
• Identify compliance errors and deviations, define corrective action plans, follow up on closures, and communicate quality and operational risks.
• Lead or participate in Quality Risk Management assessments, corrective and preventive action effectiveness activities, and continuous improvement projects.
• Maintain SOPs and on-the-job training materials while using quality and operational systems including LRT, LIMs, SAP, PacOne, QTS, and PDOCs.

Requirements

• High school diploma and at least 4 years of experience.
• Experience in the pharmaceutical industry and quality administration systems.
• Sound knowledge of current Good Manufacturing Practices as part of GxP.
• Ability to work collaboratively within quality, manufacturing, packaging, and other interdepartmental teams.
• Strong written and oral communication skills and the ability to work under short timelines while maintaining quality.
• Must be authorized to work permanently in the United States; visa sponsorship is not available now or in the future.

Nice to have

• Manufacturing-site experience.
• Experience writing and managing deviations, investigating non-conformances, performing root cause analysis, and managing change controls.
• Experience with production batch record review, ERP systems, eQMS, gLIMS, SAP, PDOCs, LRT, or Batch Tracker.

Culture & Benefits

• Collaborative work across quality, manufacturing, packaging, and interdepartmental teams.
• Benefits include a 401(k) with hirify.global matching contributions and an additional retirement savings contribution.
• Paid vacation, holidays, personal days, caregiver and parental leave, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Relocation assistance may be available based on business needs and eligibility.