Manufacturing Quality Assurance Specialist

3 weeks ago

Portage, Michigan, United States Aquestive Therapeutics Full time
Job Summary

The Manufacturing Quality Assurance Associate is responsible for ensuring quality and compliance during the day-to-day operations in the manufacturing environment by partnering with operations, supply chain, engineering, quality control, or other functions to support product quality.

This role provides GMP oversight through guidance against internal SOPs, WI, Protocols and Records as it pertains to manufacturing activities for development and commercial manufacturing.

Responsibilities:
  • Monitors all operations pertaining to manufacturing to ensure adherence to AQST policies and procedures and provides guidance and clarity to colleagues to ensure consistent approaches to product quality are applied.
  • Conducts routine internal audits and facility walkthroughs to ensure compliance with internal quality system requirements and to maintain a state of audit readiness.
  • Initiates and investigates nonconformance's, project managing to resolve quality issues by partnering with other functions.
  • Author and review Forms, Batch Records, WI, SOPs, Protocols in electronic document management system
  • Investigates assigned product quality complaints utilizing knowledge of the manufacturing and quality processes at Aquestive
  • Owns CAPA records and action item implementation, partnering with operations, supply chain, engineering, and QC staff to ensure corrective actions are implemented according to approved timelines and ensuring their effectiveness post-implementation.
  • Coordinates the Environmental Monitoring program including scheduling of third-party water testing, sampling, and report generation
  • Short to medium term (3-12 months) project owner for quality projects to improve efficiency or compliance profile
  • Understands the manufacturing schedule and provides quality support to ensure business continuity and seamless transitions between manufacturing stages.
  • Operates with a sense of urgency in a fast-paced environment.
  • Performs real time review of operational records, including Batch Records, and assists in obtaining any required corrections.
  • Performs AQL Testing on finished product by verifying various attributes such as product appearance, product and packaging dimensions, presence and accuracy of printing on strip and pouch, and seal integrity.
  • Performs line clearances for all steps of the manufacturing process.
  • Reviews, assesses, and archives pest control documents.
  • Maintains QA Retain Program, including sampling, inventory management and inspections required per internal SOPs.
  • Leads process for ensuring manufacturing environment is in a state of control through the evaluation of the building automated system software, in partnership with Maintenance.
  • Determines, documents and communicates when facility may be released back to cGMP operations after a shutdown, environmental excursion, etc.
  • Performs other duties as instructed by quality management.
  • Acknowledges that this position requires off-hours and weekend work from time to time to assure adequate QA floor support.
Qualifications:
  • BS degree preferred preferably in chemistry, biochemistry, or related science field.
  • 5+ years of related experience in the pharmaceutical, biotechnology, or medical device industry responsibility preferred.
  • Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements for the manufacture, testing, and release of pharmaceutical products.
  • Formal training in Quality disciplines (auditing, engineering, process improvement) as demonstrated through certification (ASQ, Lean Six Sigma, etc.) highly preferred.
  • Technical proficiency at reviewing/auditing production records, reports and/or GMP related documentation.
  • Ability to work within a team environment and willingness to contribute to the overall goals of the company.
  • Ability to lead project teams.
  • The ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.
  • Good organizational skills, high level of attention to detail, excellent oral and written communication skills with the ability to interact at all levels.
  • Owns a driver's license and can travel between production facilities ( Must be willing to work off hour shifts and weekends as necessary.

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