Quality Systems Specialist

TL;DR

Quality Systems Specialist: Ensuring regulatory compliance and product safety for compounded medications with an accent on batch record issuance, documentation review, and deviation management. Focus on maintaining adherence to USP standards, cGMP, and GDP requirements to support audit readiness and continuous quality improvement.

Location: On-site in New Albany, Ohio

Salary: $30 – $35 per hour

Company

hirify.global is a leading health and wellness platform dedicated to providing accessible, personalized care through an innovative, customer-first approach.

What you will do

• Manage batch record issuance for compounded lots and perform detailed reviews of executed records and test results.
• Audit documentation for compliance with ALCOA+ principles and ensure timely filing and archival of records.
• Participate in the escalation, investigation, and closure of deviations and out-of-specification results.
• Collaborate with cross-functional teams including Compounding, Pharmacy, and Quality Control to ensure consistent documentation.
• Provide trending data and metrics to management to identify continuous improvement opportunities.
• Support internal and external audits by providing necessary documentation and evidence.

Requirements

• Must be based in or able to work on-site in New Albany, Ohio.
• Bachelor’s degree in a relevant discipline or 3+ years of experience in quality, manufacturing, or a regulated industry.
• Strong understanding of USP standards (795, 797, 800), FDA 21 CFR Parts 210 & 211, cGMP, GDP, and GLP practices.
• Proven experience with investigations, deviation management, and escalation procedures.
• Proficiency in Google Workspace and familiarity with quality systems software.
• Excellent attention to detail and organizational skills.

Culture & Benefits

• Comprehensive Total Rewards package including potential equity grants.
• Commitment to a diverse, ethical, and inclusive workplace.
• Supportive environment focused on wellness and professional growth.
• Opportunities to work on high-impact healthcare solutions.