GCP Auditor / QA Manager

GCP Auditor / QA Manager
  • Competitive
    HOUR
  • Permanent
  • Raleigh NC, US Raleigh Wake Co. US 27612
Job Ref: JO000118283
Sector: Clinical
Sub-sector: Clinical
Date Added: 23 June 2021


GCP Auditor / Quality Assurance Manager - King of Prussia, PA or REMOTE

SRG is looking for a GCP Auditor / Quality Assurance Manager for a client of ours in King of Prussia, PA. This person would have the opportunity to join the Quality Management team and truly make an impact in the work that they are doing. Your responsibilities would include but not limited to:

Communication:

  • Communication with Company divisions/operational offices with regard to internal systems and locations audits
  • Communication with vendors with regard to vendor qualification audits
  • Backup communication line for customer or third party auditors with regard to issues pertaining to systems audits
  • Communication with project teams or Company divisions/offices with regard to follow-up on and resolution of quality assurance (QA) audit observations requiring corrective action
  • Communication with clients with regard to QA audits contracted to us
  • Communication with project teams and Company divisions with regard to quality management review of essential study documents.
  • Backup communication line for project teams with regard to onsite/in-house quality assurance study audits and audits of the clinical trial databases

Planning and Scheduling:

  • Preparation, conduct, and reporting of internal systems audits
  • Preparation, conduct, and reporting of internal locations audits, including remote QA assessments
  • Preparation, conduct, and reporting of vendor qualification, including remote assessments and onsite audits
  • Preparation, conduct, and reporting of contracted QA study audits
  • Preparation, conduct and reporting of mock onsite regulatory inspections
  • Oversight of the preparation, conduct, and reporting of internal study audits by QA Auditors
  • May be involved in the preparation, conduct, and reporting of the audits of CSRs
  • May be involved in the preparation and implementation of corrective action plans in response to external systems audits observations requiring corrective action
  • May be involved in the oversight of the preparation and implementation of corrective action plans in response to client/third party study audits observations requiring corrective actions

Training:

  • Participation in training of the staff in quality management issues

Quality management

  • Participation in the CAPA investigation process
  • Participation in the investigations of suspected research misconduct
  • Participation in the QM review of essential study documents
  • Participation in the review of computer systems validation documentation
  • Providing assistance and feedback to staff with regards to various GCP, regulatory compliance, and other QM matters

Qualifications

  • College or university degree MD, PharmD or degree in life sciences is a plus
  • At least 5 years of experience in Clinical Research
  • At least 3-year industry experience in the capacity of a QA auditor or equivalent
  • Must have experience in planning, conducting and reporting all types of quality assurance audits
  • Auditing experience in USA
  • Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations
  • Team oriented with superior communication and interpersonal skills
  • Strong time management, organizational, planning and presentation skills
  • Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
  • Intermediate proficiency in MS Office (Word, Excel Power Point, Outlook)
  • Must be a reasonably effective public speaker

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

#LI-MROD #LI-Remote

SRGTalent
31/07/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Melissa Rodrigues

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