Quality Assurance Auditor

HTI
  • Greenville, SC
  • Quick Apply
16 days ago

Job Description

HTI is hiring In-Process Quality Assurance Auditors for PAI in Greenville, SC. These are Direct Hire, Full-Time, 12-Hour Shifts positions with starting at $25, plus $1.25/hour shift differential for night shifts. EXCELLENT, comprehensive benefits package provided. Work in a climate-controlled pharmaceutical manufacturing environment within a regulated facility.


Job Summary – In-Process Quality Assurance Auditor
Ensures consistent product quality through independent in-process inspection, testing, verification, and auditing of pharmaceutical products during manufacturing and packaging operations in a cGMP-regulated environment. This role supports real-time compliance, documentation accuracy, and quality decision-making on the production floor.

What We Offer
  • Full benefits package – Medical, Dental, Vision, EAP, 401(k) with company match
  • 12HR day and 12HR night shifts available
  • Night shift differential ($1.25/hour)
  • Paid Time Off and company holidays
  • Stable, direct-hire role in a regulated pharmaceutical environment
  • Climate-controlled manufacturing facility
  • Nicotine-free campus supporting employee wellness

What You Need 
  • High School Diploma or GED required (Associate degree preferred)
  • Minimum 2 years of QA or QC experience in a regulated manufacturing environment
  • Strong understanding of cGMP and FDA regulations
  • Experience reviewing batch records and GMP documentation
  • Ability to work independently with minimal supervision
  • Strong attention to detail and documentation discipline
  • Ability to manage shifting priorities in a fast-paced manufacturing environment
  • Willingness to work 12-hour shifts and travel between nearby buildings during shift

Responsibilities –
  • Perform in-process inspections and audits during manufacturing and packaging operations
  • Verify executed documentation for accuracy, completeness, and data integrity
  • Conduct in-process testing (pH, specific gravity, sampling, compounding calculations)
  • Identify, document, and escalate non-conformances and deviations
  • Initiate events in TrackWise and support investigations and CAPAs
  • Perform line and room clearance inspections prior to production start
  • Verify labeling, serialization/aggregation (DSCSA), and component reconciliation
  • Collaborate with Manufacturing, Packaging, and Quality teams to resolve quality issues
  • Support SOPs, work instructions, and continuous improvement initiatives
  • Follow all company policies, procedures, and applicable regulatory requirements

INDPRO

Numbers & Facts

LocationGreenville, SC

Skills

  • Auditingunmatched
  • Biotech and Pharmaceuticalunmatched
  • Continuous Improvementunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Data Qualityunmatched
  • Detail Orientedunmatched
  • Documentationunmatched
  • Drug Manufacturingunmatched
  • FDA Requirementsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • High School Diplomaunmatched
  • Manufacturingunmatched
  • Manufacturing Auditunmatched
  • Manufacturing Operationsunmatched
  • Problem Solving Skillsunmatched
  • Process Qualityunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • Reconciliationunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Testingunmatched

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