Pharma Quality Assurance Specialist - 2nd/3rd Shift

Aquestive-Therapeutics-Inc; Portage (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Aquestive Therapeutics, Inc. seeks a Manufacturing Quality Associate to oversee quality and compliance in day-to-day manufacturing operations on 2nd and 3rd shifts in Portage, IN. The role partners with operations, supply chain, engineering, and QC to support product quality.

The MQA will provide GMP oversight against SOPs, WI, and protocols, manage CAPAs and environmental monitoring, and lead quality projects to improve efficiency and compliance. Two shifts available, with off-hours expected.

Qualifications

• Knowledge of quality systems, GMPs, industry standards, and regulatory requirements for pharma manufacturing.
• Formal training in quality disciplines (auditing, engineering, process improvement) such as ASQ or Lean Six Sigma is highly preferred.
• Ability to review/audit production records, reports, and GMP documentation.

Responsibilities

• Monitors manufacturing operations to ensure adherence to AQST policies and procedures and provides guidance to colleagues on product quality.
• Performs routine internal audits and facility walkthroughs to maintain audit readiness.
• Initiates and investigates nonconformances; leads project management to resolve quality issues with cross-functional teams.
• Authors and reviews Forms, Batch Records, WI, SOPs, and Protocols in the electronic document system.
• Investigates product quality complaints using manufacturing and quality process knowledge.
• Owns CAPA records and implement actions with cross-functional teams to ensure timely and effective corrective actions.
• Coordinates Environmental Monitoring including scheduling third-party water testing, sampling, and reporting.
• Leads quality improvement projects to enhance efficiency and compliance within 3–12 months.
• Ensures quality support aligns with manufacturing schedules and supports business continuity.
• Performs real-time review of batch records and other operational records for required corrections.
• Conducts AQL testing on finished products for attributes like appearance, dimensions, printing accuracy, and seal integrity.
• Performs line clearances for all steps of manufacturing.

Skills

Quality systems knowledge

GMP knowledge

Regulatory compliance

Education

Bachelor's degree in chemistry/biochemistry or related field

Job description

Aquestive Therapeutics, Inc. seeks a Manufacturing Quality Associate to oversee quality and compliance in day-to-day manufacturing operations on 2nd and 3rd shifts in Portage, IN. The role partners with operations, supply chain, engineering, and QC to support product quality.

The MQA will provide GMP oversight against SOPs, WI, and protocols, manage CAPAs and environmental monitoring, and lead quality projects to improve efficiency and compliance. Two shifts available, with off-hours expected.