Manufacturing Quality Assurance Specialist

4 weeks ago

Kent, Ohio, 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.

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.
  • 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.
  • Ability to lead project teams.
  • 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 (

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