Overview

Technical Laboratory Assistant, Kona Hospital (DLS Big Island) Jobs in Kealakekua, HI at Diagnostic Laboratory Services, Inc.

Piper Health & Sciences is seeking a detail-oriented and organized Quality Assurance Auditor to join a well-established biotechnology company in the Elkridge, MD area.

Responsibilities of the QA Auditor:

Review, process, and approve executed GMP documentation
Responsible for the initiation, tracking and, closure of quality records such as change controls, CAPAs, deviations, and OOS records
Perform QA on-the-floor activities including reviewing real-time batch record documentation, room release, observing critical processes, visual inspection, and handling any issues throughout the manufacturing process
Approve and release of raw materials
Assist with tracking and reporting of quality activities and approve cGMP logbooks

Qualifications of the QA Auditor:

2+ years of experience working in a GMP environment (Biotechnology or Pharmaceutical organization) in quality assurance (QA) position
Experience working with change controls, CAPAs, deviations and, out-of-specification (OOS) records is required
QA on-the-floor experience preferred
Experience gowning to perform QA functions in a manufacturing environment in ISO 5-8 cleanrooms
Strong GMP knowledge
Bachelor’s degree in science-related field

Benefits of the QA Auditor:

Salary: Between $27.00 – $37.00/hourly based on years of experience
Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave as required by law

This job opens for applications on 04/11/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

QA auditor, quality assurance auditor, quality assurance, quality assurance specialist, quality assurance technician, QA technician, QA specialist, QA on the floor, manufacturing, manufacturing associate, mastercontrol, quality management system, QMS, cGMP, current good manufacturing practice, GMP, good manufacturing practice, ISO, cleanrooms, critical processes, supplier change notifications, cGMP logbooks, logbooks, deviations, change controls, CAPA, Out of Specification, OOS, room release, raw materials, batch records, real time batch, visual inspection, FDA, regulatory agency inspection, quality compliance, product complaints, supplier complaints, vendor audits, supplier audit, audit, SOP, standard operating procedure

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Job Id:
140155

Job Category:

Job Location:
Elkridge, MD

Security Clearance:
No Clearance

Business Unit:
Piper Companies

Division:
Piper Clinical Solutions

Position Owner:
Brittany Kaplan

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Title: Technical Laboratory Assistant, Kona Hospital (DLS Big Island)

Company: Diagnostic Laboratory Services, Inc.

Location: Kealakekua, HI

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