Trinity Consultants - Albany, NY

posted about 2 months ago

Full-time - Mid Level
Albany, NY
Professional, Scientific, and Technical Services

About the position

ADVENT is seeking an On-Site Project/Administrative Coordinator to join our dynamic team in Upstate New York. Our company specializes in providing a range of engineering services including process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start-up and commissioning, as well as validation and compliance consulting for leading biotechnology and pharmaceutical manufacturing companies. The successful candidate will collaborate closely with a team of engineers dedicated to the design, automation, commissioning, and start-up of various processes, systems, and facilities. This position offers an exceptional opportunity to contribute to our growing organization and make a significant impact in the industry. In this role, the primary responsibilities will include tracking Corrective and Preventive Actions (CAPA) and Corrective Action Plans (CAPFs) from initiation through to closure, ensuring that any extensions are monitored effectively. The coordinator will also be responsible for providing monthly breakdowns of CAPAs initiated and owned by the FMM department. Additionally, the role involves tracking BMRAM Workflows, primarily focusing on TSCRs, which includes reaching out to approvers of BMRAM records for prioritization and maintaining relevant data and metrics related to TSCRs. General administrative duties will encompass scheduling meetings, maintaining agendas and notes, and following up on necessary action items to ensure smooth operations. The ideal candidate will possess strong analytical skills with a keen attention to detail, as well as excellent written, verbal, and interpersonal communication skills. The ability to work independently in a fast-paced environment with tight deadlines is essential, along with the capability to handle multiple projects simultaneously. Advanced proficiency in Microsoft Office applications, particularly Excel, PowerPoint, and Word, is required. Experience with Computerized Maintenance Management Systems (CMMS) or other databases, along with project management experience, will be advantageous. A background in technical operations or quality assurance is also a plus. Candidates should hold a minimum of a BS/BA in a scientific or engineering discipline, coupled with at least 3 years of related experience in cGMP manufacturing operations, whether in clinical or commercial drug products. This position offers a competitive salary range of $80,000 to $100,000 USD, and applications will be accepted until the role is filled. Please note that only those applicants selected for an interview will be contacted, and we kindly request no phone calls regarding this position.

Responsibilities

  • Tracking CAPA and CAPFs from initiation through closure, including monitoring any extensions.
  • Providing monthly breakdowns of CAPAs initiated and owned by the FMM department.
  • Tracking BMRAM Workflows (primarily TSCRs) and reaching out to approvers for prioritization.
  • Maintaining data and metrics related to TSCRs.
  • Scheduling meetings and maintaining agendas and notes.
  • Following up on necessary action items.

Requirements

  • A minimum of BS/BA in scientific or engineering discipline.
  • 3+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).
  • Strong analytical skills with attention to detail.
  • Excellent written, verbal, and interpersonal communication skills.
  • Ability to work independently within a tight deadline environment.
  • Experience handling multiple projects simultaneously.
  • Advanced experience with Microsoft Office (Excel, PowerPoint, Word).
  • Experience with CMMS systems or other databases.
  • Project Management Experience.
  • Technical operations and/or quality experience are a plus.

Nice-to-haves

  • Experience with CMMS systems or other databases.
  • Project Management Experience.
  • Technical operations and/or quality experience.
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