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Quality Assurance Associate

HireTalent

Winchester, KY

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JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Cleaning Equipment, Coaching, Code of Federal Regulations, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Data Collection, Documentation Review, Environmental Monitoring, GMP (Good Manufacturing Practices), High School Diploma, J D Edwards, Maintain Compliance, Manufacturing, Manufacturing Requirements, Physical Inventory, Procedure Implementation, Product Testing, Quality Assurance, Quality Management, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis, Safety Compliance, Safety Standards, Shipping/Receiving, Standard Operating Procedures (SOP), Training/Teaching
LOCATION
Winchester, KY
POSTED
9 days ago
Job Title: Quality Assurance Associate
Duration : 6 Months on W2 (Temp to Hire)
Location: Winchester, KY
Shift: Monday Friday, 6:00 AM 2:30 PM (Mandatory Overtime Required)

Job Summary:
The Quality Assurance Associate is responsible for ensuring compliance with cGMP standards, SOPs, and regulatory requirements in the manufacturing of solid oral dosage pharmaceutical products. This role supports real-time quality oversight, documentation review, environmental monitoring, and cross-functional collaboration to maintain product quality and compliance.

Key Responsibilities:
  • Review and recommend updates to SOPs and batch records
  • Provide feedback on proposed SOP revisions to management
  • Perform real-time batch record audits for accuracy, completeness, and compliance
  • Conduct room and equipment clearance following cleaning procedures
  • Perform environmental monitoring, including microbial swabbing of equipment and surfaces
  • Ensure adherence to SOPs, cGMP, and CFR guidelines
  • Conduct in-process and finished product testing such as:
  • Particle size
  • Bulk density
  • Moisture analysis
  • Appearance checks
  • AQL testing
  • Monitor manufacturing areas for compliance with quality and safety standards
  • Identify and help resolve deviations to prevent production impact
  • Initiate and document deviation reports in TrackWise with detailed findings
  • Manage quality status of WIP and finished goods in JD Edwards and physical inventory
  • Support deviation investigations, including data collection and root cause analysis
  • Enforce GMP compliance across operations
  • Assist with customer complaint investigations
  • Provide training and coaching to manufacturing staff as needed
  • Support continuous improvement initiatives (CAPAs, training, efficiency projects)
  • Collaborate cross-functionally to assess quality impacts and investigations

Qualifications:
Minimum Requirements:
  • Bachelor s Degree OR
  • Associate s Degree with 1+ year of relevant experience OR
  • High School Diploma/GED with 2+ years of relevant experience











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