Quality System Associate

2 weeks ago

North Billerica, 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 supporting the Quality Policy and Operating Procedures and providing effective solutions. Actively involved with Quality System Management, Quality Improvements and must have a constant awareness of Customer Requirements. Must be oriented to making metric-driven decision making; maintain accurate and concise record keeping; uphold 21 CFR Part 820 and ISO 13485 requirements; partner with internal customers and suppliers; and supporting management decisions concerning growing the Business Strategy. Implement and maintain the Documentation Control system, which includes the electronic Documentation Management system. Revision Control, processing ECOs, and updating the affected drawings and specifications. All tasks are performed in compliance to 21 CFR 820.40 Subpart D Document Controls.

Key Duties:

Tasks/Duties/Responsibilities:

  • Perform Quality System audits.
  • Identify improvement opportunities and implement change
  • Quality Management functions (i.e. CAPA's, Internal and External Audits, Complaint Investigations, Product release, MRB, Quality reports, regulatory registration support as needed) using basic Quality Assurance principles and methodology under the guidance of your Manager.
  • Ensure compliance with the organizations policies and all applicable national (FDA 21 CFR Part 820) and international quality standards and regulations (i.e. ISO) regarding Documentation Control. Work with R&D, Manufacturing, Product Support and Marketing to improve product quality to meet current cGMP standards.
  • Develop and maintain standard operating procedures (SOPs). Review ECOs and other documents for accuracy, approve and reject tasks, notify initiator/author when training can be completed. Review and process as needed manufacturing/test procedures for products and raw materials for release into inventory and shipping. Organize and track the training program for all employees.
  • Create and maintain BOMs and item master in ERP system.
  • Maintain records and indexes of all documents stored off-site.
  • Assure all 510(k)s, DHF, Validations and master document files are in a locked, controlled environment, with access limited to Quality Assurance employees and other department officials on an as needed basis.
  • Prepare materials as needed for 3rd party audits and maintain objective evidence documents.
  • Update management with bi-weekly and quarterly metrics as defined by your Manager.

Other Duties & Physical Requirements:

  • 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.
  • Ability to stand and/or sit for long periods of time.


Qualifications:

Minimum Education or Equivalent Experience Required/Preferred:

  • Bachelor of Science Degree or equivalent experience required.
  • At least 2 years of experience in QA, QC within a FDA regulated environment required. Project Management preferred.

Competencies Required or preferred:

  • Knowledge of cGMP/QSRs, FDA device regulations, ISO 13485
  • Able to use Microsoft Office (Microsoft Word, Excel, PowerPoint)
  • 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.
  • 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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