Manufacturing Quality Associate — 2nd/3rd Shift

Aquestive Therapeutics, Inc.; Portage (IN); On-site; USD 60,000 - 85,000; Full time

Job summary

Aquestive Therapeutics, Inc. is seeking a Manufacturing Quality Associate (MQA) for 2nd and 3rd shifts in Portage, IN. The role ensures quality and compliance in day-to-day manufacturing by partnering with operations, supply chain, engineering, and QC to support product quality.

GMP oversight is provided against SOPs, WI, protocols, and records for development and commercial manufacturing. The MQA will conduct internal audits, investigate nonconformances, manage CAPA, and author/review essential

Qualifications

• BS degree in chemistry, biochemistry, or related science field.
• 5+ years of related experience in pharma/biotech/medical devices.

Responsibilities

• Monitors manufacturing operations to ensure AQST quality adherence.
• Drives internal audits and facility walkthroughs for audit readiness.
• Initiates investigations and CAPA to resolve quality issues with cross-functional teams.
• Author/review batch records, WI, SOPs, and protocols in the electronic document system.
• Investigates product quality complaints with manufacturing and QC knowledge.
• Owns CAPA records and ensures timely corrective actions and effectiveness.

Skills

Quality systems

GMP knowledge

Auditing

Project leadership

Time management

Education

BS degree in Chemistry or related science

Job description

Aquestive Therapeutics, Inc. is seeking a Manufacturing Quality Associate (MQA) for 2nd and 3rd shifts in Portage, IN. The role ensures quality and compliance in day-to-day manufacturing by partnering with operations, supply chain, engineering, and QC to support product quality.

GMP oversight is provided against SOPs, WI, protocols, and records for development and commercial manufacturing. The MQA will conduct internal audits, investigate nonconformances, manage CAPA, and author/review essential