Advanced Quality Assurance Specialist

1 month ago


Portage, Indiana, United States Ursitti Enterprises LLC Full time
Job Description

Ursitti Enterprises LLC is seeking a highly skilled Advanced Quality Technician to join their team at the Portage Facility. The ideal candidate will have a strong background in quality systems, GMPs, and regulatory requirements for the manufacture, testing, and release of pharmaceutical products.

Key Responsibilities:

  • Provide GMP/GDP guidance to ensure proper actions and documentation occur within the manufacturing space.
  • Perform AQL testing on finished products by verifying various attributes such as product appearance, product and packaging dimensions, presence and accuracy of printing on strip and pouch, and seal integrity.
  • Perform line clearances for all steps of the manufacturing process.
  • Review and assess pest control documents.
  • Conduct QA retain sampling, analysis, and documentation of results.
  • Perform problem-solving/troubleshooting for incidents observed and initiate event reports for incident resolutions.
  • Ensure the manufacturing environment is in a state of control by evaluating the building's automated system software.
  • Conduct routine audits and walkthroughs to ensure audit readiness.
  • Verify schedule and workflow adherence.
  • Communicate non-conforming events to the Manufacturing Quality Associate and Operations Team Leads and management.

Requirements:

  • BS degree 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.
  • Owns a driver's license and can travel between production facilities (< 1 mile) as required.
  • Must be willing to work off-hour shifts and weekends as necessary.
  • Can carry or lift up to 35lbs.
  • Be able to pass vision and hearing tests as required.
  • Can spend up to 65% of the shift working while standing or moving.


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