In Process Quality Coordinator

HTI
  • Greenville, SC
  • Quick Apply
3 days ago

Job Description

HTI is hiring an In-Process Quality Assurance Coordinator for PAI in Greenville, SC. These are Direct Hire, Full-Time, 2nd Shift position with starting at $27, 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 Coordinator
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

Responsibilities –
  • Follows all policies, procedures, SOPs, cGMP, Work Instructions, and supervisor instructions.
  • Perform verification of manufacturing operations. 
  • Collects samples and performs in-process testing (pH, dissolved oxygen, titrations, etc.) and assay calculations for compounding operations. 
  • Perform batch calculations and QS verifications.
  • Collects samples and performs TOC analysis on clean equipment. 
  • Perform daily checks on the TOC levels of the purified water system.
  • Collects and maintains data for quality reporting. 
  • Support the development and revision of SOPs, Work Instructions (WIs), and related quality documents.
  • Maintain up-to-date knowledge of cGMPs, regulatory requirements, and company quality policies.  Promote cGMP compliance in an FDA/DEA regulated pharmaceutical manufacturing environment. 
  • Participate in continuous improvement activities to enhance product quality and operations efficiency.  
    Perform in-process inspections and audits during manufacturing and packaging operations

INDPRO

Numbers & Facts

LocationGreenville, SC

Skills

  • Analysis Skillsunmatched
  • Assaysunmatched
  • Auditingunmatched
  • Biotech and Pharmaceuticalunmatched
  • Continuous Improvementunmatched
  • Corporate Policiesunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Data Collectionunmatched
  • Detail Orientedunmatched
  • Documentationunmatched
  • Drug Manufacturingunmatched
  • FDA (Food and Drug Administration)unmatched
  • FDA Requirementsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • High School Diplomaunmatched
  • Manufacturingunmatched
  • Manufacturing Auditunmatched
  • Manufacturing Operationsunmatched
  • Process Managementunmatched
  • Process Qualityunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • Quality Managementunmatched
  • Regulatory Requirementsunmatched
  • Specimen Collectionunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Testingunmatched
  • Titrationunmatched
  • United States Drug Enforcement Agency (DEA)unmatched

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