Manufacturing Quality Assurance Technician

4 weeks ago

Portage, United States Aquestive Therapeutics Full time


Job Summary:

Partners with operations to lead in the development, implementation and maintenance of quality systems that support the day-to-day manufacturing operations in order to meet product and process quality metrics.  Through leadership, provides GMP oversight through guidance against the health authority regulations. Performs product sampling and testing to support drug product manufacturing, troubleshoots quality issues, issues line-clearances and facility releases.  When necessary, also assists with problem solving and investigation of nonconformance, real time and post manufacturing document reviews, and coordinates workflows and events. 

Job Responsibilities:

  • Provides GMP/GDP Guidance to ensure proper actions and documentation is taking place within the manufacturing space.
  • 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.
  • Perform real time record review to ensure completeness and accuracy of the documentation and assist in obtaining any required corrections.
  • Reviews, assesses, and archives pest control documents.
  • Performs QA retain sampling; conducts analysis and documentation of results.
  • Spot checks and conducts facility walkthroughs for critical process steps to ensure adherence to policies, procedures and regulations.
  • Conducts problem solving/trouble shooting for incidents observed and initiates event reports for incident resolutions
  • Understands the manufacturing schedule and provides quality support to ensure business continuity. Ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.
  • Operates with a sense of urgency in a fast-paced environment.
  • Ensures that the manufacturing environment is in a state of control through the evaluation of the building automated system software
  • Conducts routine audits and walkthroughs to ensure audit readiness at all times.
  • Verifies schedule and workflow adherence.
  • Communicates any non-conforming events (testing results, environmental conditions, documentation issues, etc.) to the Manufacturing Quality Associate and Operations Team Leads and management.
  • Performs other duties as instructed by quality management.
  • Leads and participates in special projects.
  • Acknowledges that this position requires off-hours and weekend work from time to time to assure adequate QA floor support while production is running.

Job Qualifications:

  • BS degree preferred in chemistry, biochemistry, or related science field highly desired.
  • 3+ years of related experience in the pharmaceutical, biotechnology, or medical device industry with increasing responsibility preferred.
  • Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements for the manufacture, testing, and release of pharmaceutical products.
  • 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.
  • Strong technical writing skills.
  • Good problem-solving techniques and a demonstrated ability to troubleshoot.
  • Good organizational skills, high level of attention to detail, excellent oral and written communication skills with the ability to interact at all levels both internally and externally.
  • Experience working directly with regulatory agencies a plus.
  • Ability to lift up to 35lbs.
  • Must be willing to work off hour shifts and weekends as necessary.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing.  Please Note:  Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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