Quality Assurance Associate

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)

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.

• 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.

Candidates must meet one of the following:

• Bachelors Degree; OR
• Associates 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.

• 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.