Quality Assurance Associate

4 weeks ago

Cincinnati, United States Meridian Bioscience Full time

About Meridian:

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary:

Responsible for working with more senior colleagues in supporting Meridian's Quality Policy and Operating Procedures. Contributes ideas for Quality System Management, Quality Improvements, maintains accurate and concise record keeping in accordance with 21 CFR Part 820, ISO 13485 and 98/79 EC requirements; partners with internal customers and suppliers.

Key Duties:

Tasks/Duties/Responsibilities:

  • Assist with all activities related to management of Meridian's Quality System.
  • Support daily activities of the organization to ensure on-time delivery of high quality products.
  • Review deviations, CAPAs and OOS to assure quality system and regulatory compliance. Maintain electronic and paper files.
  • Participate as subject matter expert regarding the CAPA, OOS, deviation and complaint processes.
  • Prepare and evaluate trends in quality system to monitor effectiveness. Utilize statistical methods for analysis.
  • Perform risk based analysis using quality, compliance and business needs.

Other Duties/Physical Requirements:

  • Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility
  • Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.).
  • Must be able to adhere to applicable bio-safety practices when on the manufacturing floor.
  • Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
  • Must be able to analyze, concentrate, and solve complex issues throughout the workday


Qualifications:

Minimum Education or Equivalent Experience Required/Preferred:

  • Bachelor of Science Degree or equivalent experience required.
  • At least 1 year experience in QA, QC within a FDA regulated environment required.

Competencies Required or preferred:

  • Knowledge of cGMP/QSRs, FDA device regulations, ISO 13485
  • Thoroughly understands and can apply regulations and standards to new situations
  • Ability to write, review, execute deviations, CAPAs, OOS and complaints.
  • Previous experience with ERP systems, electronic document management systems preferred
  • Ability to read, understand and follow all company SOPs and guidelines.
  • Utilize critical thinking skills to problem solve and troubleshoot.
  • Ability to communicate (written and verbal) and interact effectively with all levels of the organization.
  • Good organizational skills and strong attention to detail.
  • Must be able to perform job requirements independently with minimal supervision.
  • Adjusts easily and readily to a fast-paced work environment with changing priorities
  • Proficient in Microsoft Word and Excel.
  • Detail and process oriented.


Required Travel %:

  • Not Anticipated

*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*

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