QA Associate I — Pharma Manufacturing (Night Shift, Onsite)

Pinnaql; Winchester (KY); On-site; USD 52,000 - 58,000; Full time

Job summary

Pinnaql in Winchester, KY is seeking a detail-oriented Quality Assurance (QA) Associate I to support real-time quality oversight in a GMP manufacturing environment. The position requires ensuring products are manufactured in compliance with cGMP regulations, FDA requirements, and internal SOPs, with emphasis on quality standards and accurate documentation.

This 6-month contract with potential for temp-to-hire offers on-site night shift (Friday–Sunday 6:00 PM–6:00 AM plus another weekday every

Qualifications

• Bachelor's Degree or equivalent qualification in related field.
• Associate's Degree with 1+ year of related pharmaceutical, biotechnology, food manufacturing, or regulated industry experience.
• High School Diploma/GED with 2+ years of related quality or manufacturing experience.

Responsibilities

• Provide real-time QA support during pharmaceutical manufacturing operations.
• Review batch production records for accuracy, completeness, calculations and compliance with procedures.
• Conduct room and equipment clearance inspections following production cleaning activities.
• Perform environmental monitoring, including microbial surface swabbing.
• Monitor manufacturing operations to ensure compliance with cGMP, SOPs, batch records and safety.
• Perform routine in-process and finished product quality testing including Particle Size Analysis.
• Perform Bulk Density, Moisture Analysis and Visual Inspection.
• Conduct AQL (Acceptable Quality Level) Testing where required.
• Recommend improvements to SOPs and batch records when appropriate.
• Review proposed SOP revisions and provide feedback.
• Initiate and document quality deviations using TrackWise.
• Assist with deviation investigations, root cause analysis, and CAPA.
• Manage quality status of WIP and finished goods in JD Edwards ERP.
• Complete investigations related to customer complaints.
• Support GMP compliance initiatives and continuous process improvement projects.
• Provide training and coaching to manufacturing personnel as needed.
• Collaborate with cross-functional teams to resolve quality-related issues.

Skills

Attention to detail

Communication

Problem solving

Education

Bachelor's Degree

Associate's Degree

High School Diploma/GED

Tools

TrackWise

JD Edwards ERP

Job description

Pinnaql in Winchester, KY is seeking a detail-oriented Quality Assurance (QA) Associate I to support real-time quality oversight in a GMP manufacturing environment. The position requires ensuring products are manufactured in compliance with cGMP regulations, FDA requirements, and internal SOPs, with emphasis on quality standards and accurate documentation.

This 6-month contract with potential for temp-to-hire offers on-site night shift (Friday–Sunday 6:00 PM–6:00 AM plus another weekday every