Quality Assurance Specialist

1 week ago

Syracuse, New York, United States Trinity Consultants - Advent Engineering Full time
{"title": "Quality Assurance Specialist", "description": "Job Summary

ADVENT Engineering, a Trinity Consultants Company, is a leading engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Our company is headquartered in Dallas, TX, with operations in the Eastern US and Canada, and is involved in various aspects of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

We are seeking a Quality Assurance Specialist to join our team. The successful candidate will work with a group of Compliance Specialists involved in the creation, tracking, and closure of CAPAs associated with facilities maintenance. The ideal candidate will have a strong technical aptitude, preventative maintenance experience, and data analysis skills.

Key Responsibilities:

  • Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to implement Corrective and Preventative Actions
  • Manages and participates in Facilities Department CAPA Program. Ensures that all activities related to CAPAs are performed in a timely manner and in compliance with procedures and regulatory requirements.
  • Daily monitoring and tracking of CAPAs assigned to the facilities department.
  • Responsible for all aspects of CAPA ownership including facilitation of cross functional meetings with relevant stakeholders, completion of extension requests where applicable, and submission of evidence to QA.
  • Initiation and ownership of requests and workflows in Computerized Maintenance Management System (BMRAM)
  • Attend Weekly Meetings to discuss CAPA progress and escalation of obstacles, including presenting, taking notes, managing agenda items and invites.
  • Ownership of CAPA Effectiveness Checks including the review and analyzing of relevant data and completing reports documenting findings
  • Provides support and training for Facilities personnel on regulatory and quality topics, such as proper documentation procedures and the use of QUMAS.

Requirements:

  • Well-developed communication skills, both verbal and written.
  • Outstanding Organization skills (required to handle multiple projects concurrently)
  • Strong data analysis skills (excel, performance metrics).
  • Strong GMP background including working knowledge of preventative maintenance principles.
  • Familiar with a broad range of equipment used in pharmaceutical production, including but not limited to: bioreactors, chromatography skids, centrifuges/separators, air handlers, HEPA.

About Us:

We are committed to cultivating an authentic and diverse organization, welcoming all those interested in our work to apply. We are committed to providing an accessible and inclusive interview experience. Please inform us of any accommodations needed to assist you during the interview process.

How to Apply:

Applications will be accepted until the role is filled. Only those applicants who are selected for an interview will be contacted. No phone calls please.

", "lang_code": "en"}

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