Manufacturing Quality Associate (2nd or 3rd Shift Available)
Aquestive Therapeutics
July 01, 2026
On-site
Portage, IN
Operations
Job Summary:
The Manufacturing Quality Associate ensures quality and compliance during day-to-day manufacturing by partnering with operations, supply chain, engineering, quality control, and other functions. Provides GMP oversight and guidance against internal SOPs, WI, protocols, and records for development and commercial manufacturing.
Responsibilities:
- Monitor manufacturing operations to ensure adherence to AQST policies/procedures; provide guidance for consistent product quality.
- Conduct routine internal audits and facility walkthroughs to maintain audit readiness.
- Initiate and investigate nonconformances; manage resolution of quality issues with other functions.
- Author/review Forms, Batch Records, WI, SOPs, protocols in the electronic document management system.
- Investigate product quality complaints.
- Own CAPA records and ensure corrective actions are implemented on time and are effective.
- Coordinate the Environmental Monitoring program (third-party water testing, sampling, report generation).
- Lead 3–12 month quality projects to improve efficiency or compliance.
- Provide quality support to maintain business continuity between manufacturing stages.
- Perform real-time review of operational records and support required corrections.
- Perform AQL testing on finished product (appearance, dimensions, printing accuracy, seal integrity).
- Perform line clearances for all manufacturing process steps.
- Review, assess, and archive pest control documents.
- Maintain QA Retain Program (sampling, inventory management, inspections per SOPs).
- Support control of manufacturing environment by evaluating building automated system software.
- Determine/document/communicate release of facility back to cGMP operations after shutdown or excursions.
- Perform other duties as instructed by quality management.
Qualifications:
- BS required, preferably in chemistry, biochemistry, or related science.
- 2+ years’ experience preferred in pharmaceutical/biotech/medical device.
- Knowledge of quality systems, GMPs, industry standards, and regulatory requirements.
- Formal training/certification in quality disciplines (auditing, engineering, process improvement) highly preferred.
- Technical proficiency reviewing/auditing GMP documentation and production records.
- Ability to work in teams, lead project teams, manage multiple priorities, and communicate effectively.
- Ability to lift up to 35 lbs; willing to work off-hours/weekends as needed.
Application instructions:
- Final candidates must complete a drug test and background check prior to employment.
The Manufacturing Quality Associate ensures quality and compliance during day-to-day manufacturing by partnering with operations, supply chain, engineering, quality control, and other functions. Provides GMP oversight and guidance against internal SOPs, WI, protocols, and records for development and commercial manufacturing.
Responsibilities:
- Monitor manufacturing operations to ensure adherence to AQST policies/procedures; provide guidance for consistent product quality.
- Conduct routine internal audits and facility walkthroughs to maintain audit readiness.
- Initiate and investigate nonconformances; manage resolution of quality issues with other functions.
- Author/review Forms, Batch Records, WI, SOPs, protocols in the electronic document management system.
- Investigate product quality complaints.
- Own CAPA records and ensure corrective actions are implemented on time and are effective.
- Coordinate the Environmental Monitoring program (third-party water testing, sampling, report generation).
- Lead 3–12 month quality projects to improve efficiency or compliance.
- Provide quality support to maintain business continuity between manufacturing stages.
- Perform real-time review of operational records and support required corrections.
- Perform AQL testing on finished product (appearance, dimensions, printing accuracy, seal integrity).
- Perform line clearances for all manufacturing process steps.
- Review, assess, and archive pest control documents.
- Maintain QA Retain Program (sampling, inventory management, inspections per SOPs).
- Support control of manufacturing environment by evaluating building automated system software.
- Determine/document/communicate release of facility back to cGMP operations after shutdown or excursions.
- Perform other duties as instructed by quality management.
Qualifications:
- BS required, preferably in chemistry, biochemistry, or related science.
- 2+ years’ experience preferred in pharmaceutical/biotech/medical device.
- Knowledge of quality systems, GMPs, industry standards, and regulatory requirements.
- Formal training/certification in quality disciplines (auditing, engineering, process improvement) highly preferred.
- Technical proficiency reviewing/auditing GMP documentation and production records.
- Ability to work in teams, lead project teams, manage multiple priorities, and communicate effectively.
- Ability to lift up to 35 lbs; willing to work off-hours/weekends as needed.
Application instructions:
- Final candidates must complete a drug test and background check prior to employment.