Senior/Principal Quality Auditor
Posted on 2/5/2024
INACTIVE
PFM

501-1,000 employees

Provides financial advisory and strategic consultation services
Company Overview
PFM stands out as a leading financial advisory firm due to its commitment to providing tailored, creative consultation that goes beyond traditional financial advice, empowering and educating its clients for sustainable outcomes. The company's competitive edge lies in its diverse range of services offered through affiliated entities, all under the PFM brand, including financial advisory, swap advisory, consulting, strategic forecasting, and a web-based platform for municipal bond information. PFM's industry leadership is further demonstrated by its adherence to regulatory standards, with registrations with the SEC, MSRB, and the Commodity Futures Trading Commission.
Consulting

Company Stage

Grant

Total Funding

N/A

Founded

1975

Headquarters

Philadelphia, Pennsylvania

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

-22%
Locations
Remote in USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Word/Pages/Docs
Quality Assurance (QA)
Google Cloud Platform
PowerPoint/Keynote/Slides
CategoriesNew
QA & Testing
Requirements
  • Four to five years of applicable experience or equivalent combination of education and experience
  • Bachelor’s degree in a science, healthcare, or related field of study
  • Clinical research experience in non-QA role considered
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards
  • Hands-on experience leading clinical site audits
  • Availability to travel up to 25% domestically and/or internationally
  • QA certification preferred (e.g., CQA, SQA, etc.)
  • Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)
  • Fluency in the English language
Responsibilities
  • Support the Quality Management System including SOPs, training and CAPA
  • Process and maintain documentation for controlled documents, as required
  • Develop and administer training for employees and/or consultants
  • Host client/sponsor audits and support regulatory inspections
  • Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
  • Coordinate and conduct internal audits of quality systems
  • Coordinate and conduct investigator site audits
  • Coordinate and conduct trial master file audits
  • Participate on computer systems validation projects and systems change control process
  • Provide QA consultation and support to assigned project teams internally and externally
  • Support and manage reported quality issues and any associated corrective and preventive actions
  • Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
  • Maintain Q&C trackers, databases, metrics, and files
  • Follow applicable regulations and standards, including but not limited to local regulations (US  FDA and EU), ICH, ISO and company policies and procedures
  • Additional tasks as required
Desired Qualifications
  • CRO, Pharmaceutical and/or Medical device experience
  • Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database