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Quality Assurance Auditor

HTI LLC

Greenville, SC

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JOB DETAILS
SALARY
SKILLS
Auditing, Biotech and Pharmaceutical, Continuous Improvement, Current Good Manufacturing Practice (cGMP), Data Quality, Detail Oriented, Documentation, Drug Manufacturing, FDA Requirements, GMP (Good Manufacturing Practices), High School Diploma, Manufacturing, Manufacturing Audit, Manufacturing Operations, Problem Solving Skills, Process Quality, Quality Assurance, Quality Control, Reconciliation, Standard Operating Procedures (SOP), Testing
LOCATION
Greenville, SC
POSTED
Today
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

About the Company

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HTI LLC