Quality Assurance Associate

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

Quality Assurance (QA) Associate I – Pharmaceutical Manufacturing (Temp-to-Hire)

Location: Winchester, KY (100% Onsite)
Pay Rate: $26.38/hour (W2) Without benefits
Employment Type: 6-Month Contract with Potential for Temp-to-Hire
Shift: Friday, Saturday & Sunday | 6:00 PM – 6:00 AM + One additional weekday every other week (Mandatory Overtime Required)

Job Summary

We are seeking a detail-oriented Quality Assurance (QA) Associate I to join a leading pharmaceutical manufacturing facility. This position is responsible for providing real-time quality oversight within a GMP manufacturing environment to ensure products are manufactured in compliance with cGMP regulations, internal SOPs, FDA requirements, and quality standards.

This is an excellent opportunity for candidates looking to build or expand their career in pharmaceutical quality assurance.

Key Responsibilities

• Perform real-time QA support during pharmaceutical manufacturing operations.
• Review batch production records for accuracy, completeness, calculations, and compliance with established 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 requirements.
• Perform routine in-process and finished product quality testing, including:
  • Particle Size Analysis
  • Bulk Density Testing
  • Moisture Analysis
  • Visual Inspection
  • AQL (Acceptable Quality Level) Testing
• 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 corrective actions (CAPA).
• Manage quality status of work-in-process (WIP) and finished goods within the inventory management system (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.
• Perform additional QA responsibilities as assigned.

Required Qualifications

Candidates must meet one of the following:

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

Preferred Qualifications

• Experience working in a pharmaceutical manufacturing or other regulated GMP environment.
• Knowledge of cGMP, FDA regulations, and Good Documentation Practices (GDP).
• Experience with TrackWise, JD Edwards (JDE ERP), or similar quality/inventory systems.
• Strong attention to detail and documentation skills.
• Excellent communication and problem-solving abilities.
• Ability to work independently and in a fast-paced manufacturing environment.