Site Compliance Specialist

Site Compliance Specialist
  • Competitive
    HOUR
  • Temporary
  • Marietta PA, US Marietta LANCASTER US 17547
Job Ref: JO000122503
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 02 September 2021


SRG is a global staffing and consulting firm and we are looking for a strong Site Compliance Specialist for a 6-9 month project in Marietta, PA!

• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, and industry practice.
• Single point of contact between all Regulatory Affairs functions and site.
• Site regulatory expert – responsible for interpretation of regulatory requirements and advice regarding regulatory conformance.
• Responsible for assessing all change controls for Regulatory impact and for assessment (with Regulatory Affairs) of the level of change for change controls with regulatory impact.
• Responsible for planning all regulatory applications following the Vaccines Regulatory Submission Building process and responsible for the internal review and approval of CMC dossiers business process outlined by LSOP 9000040603.
• Responsible for planning and coordinating all responses to Regulatory information requests and the business process outlined by LSOP 9000040605, provide CMC and regulatory file information to the site.
• Responsible for organizing and coordinating the actions of teams responsible for preparing regulatory submissions so that regulatory submissions are prepared accurately, completely, and on time.
• Responsible for local coordination of license renewal requests.
• Responsible for maintaining the Core Files and the Site Master File.
• Member of the local inspection team during regulatory inspections.

#LI-KS1

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.

SRGTalent
09/10/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Kayla Sanford

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