In Process Quality Coordinator

HTI

  • Greenville, SC
  • 1 day ago

    Highlights

    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. Collects samples and performs in-process testing (pH, dissolved oxygen, titrations, etc.) and assay calculations for compounding operations.

    Numbers & Facts

    LocationGreenville, SC

    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

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