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Data Reviewer

2 months ago

Orangeburg, New York, United States PDI Full time
Job Summary

PDI is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for reviewing and approving analytical data to ensure compliance with regulatory requirements.

Key Responsibilities
  • Review and Approve Analytical Data: Ensure that all analytical data, including raw and electronic data, is accurate and compliant with regulatory requirements.
  • Support Quality Assurance: Collaborate with the quality assurance team to ensure that all testing and analysis is conducted according to approved test methods and standard operating procedures.
  • Ensure Compliance: Verify that all laboratory notebooks, reagents, standards, and equipment are within acceptable ranges and that chemists follow all SOPs and cGMP regulations.
  • Analyze and Interpret Results: Analyze and interpret results in written and oral format, and provide guidance to analysts on laboratory notebook documentation requirements.
  • Support Regulatory Audits: Support quality assurance and regulatory management during audits, and provide guidance to analysts on regulatory requirements.
Requirements
  • Education: Bachelor's degree in Chemistry or related field.
  • Experience: 4+ years related experience in pharmaceutical analysis, with cGMP/regulatory and data integrity experience preferred.
  • Skills: Ability to understand SOPs, USP/NF procedures, and requirements; ability to handle multiple responsibilities and projects; and ability to interact with senior management.
Benefits
  • Comprehensive Benefits Package: Medical, behavioral, and prescription drug coverage, health savings account, dental, vision, 401(k) savings plan with company match and profit sharing, basic and supplemental life and AD&D insurance, flexible spending accounts, short and long-term disability, employee assistance program, and health advocacy program.
  • Voluntary Benefits: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance, and employee discounts.
  • Work-Life Balance: Paid time off programs, including sick and safe leave, vacation, company and floating holidays, paid parental leave, and summer hours and flex place/flex time options.