Job Title: In-Process Quality Assurance (IPQA)
Department: Quality Assurance
Position Type: Full time
Schedule: 40 hours per week flexible to work overtime and weekends
5:30pm to 5:30am
Grave Yard

Job Overview

The In-Process Quality Assurance (IPQA) professional is responsible for ensuring that materials, in-process components, and finished products meet established quality standards and regulatory requirements. This role plays a key part in maintaining compliance with Good Manufacturing Practices (GMP) and applicable FDA regulations. The IPQA works closely with production teams to identify and resolve quality issues, perform inspections, and maintain accurate documentation to ensure consistency across the production line.

Key Responsibilities

Work Order & Material Verification

• Review work orders and ensure all materials and documentation are available before production.

• Verify materials meet specifications and resolve discrepancies with supervisors.

• Perform line clearance procedures to prevent cross-contamination.

In-Process Inspections & Compliance

• Conduct inspections of in-process and finished products.

• Pull and evaluate samples as per established procedures; coordinate testing with laboratory as needed.

• Verify packaging and labeling accuracy prior to release.

• Record and report any non-conformances, recommending corrective actions.

Documentation & Record Keeping

• Manage Device History Records (DHR) / Batch Records in compliance with GMP.

• Review records for accuracy and completeness.

• Maintain detailed inspection results and non-compliance reports.

Safety & Regulatory

• Ensure work is performed in compliance with safety protocols, GMP, and FDA regulations.

• Support a safe, compliant, and efficient production environment.

Qualifications

Education

• High school diploma or GED required.

• Associate degree in a related field preferred.

Experience

• Previous experience in quality assurance, inspection, or quality control in a regulated industry (pharmaceutical, medical device, or food production) preferred.

Skills & Abilities

• Strong attention to detail and observational skills.

• Basic proficiency in Microsoft Office (Excel, Word).

• Good mathematical and organizational skills.

• Ability to multitask and work effectively with production teams.

• Bilingual skills are a plus.

Other Requirements

• Strong work ethic and commitment to quality.

• Problem-solving skills with the ability to resolve quality issues quickly.

• Understanding of compliance standards and willingness to uphold them consistently.
  
  
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