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ID 273 Regulatory Compliance Auditor Job
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| Employer Name: |
SpiderID: 2216745 |
| Location: Long Island, New York |
Date Posted: 5/7/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: JS 273 |
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Job Description:
Job Description Under general supervision, conducts internal Good Manufacturing Practice audits to assure compliance with Food and Drug Administration regulations and Company requirements.
• Carries out auditing responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Conducts internal audits at manufacturing and distribution facilities such as manufacturing, packaging, label control, storage, warehousing, distribution and laboratories to ensure compliance with Food and Drug Administration (FDA), current Good Manufacturing Practices (cGMP), EU regulations, ICH guidelines, Drug Enforcement Agency (DEA) regulations, departmental specifications and Standard Operating Procedures (SOPs).
• Interacts with corporate auditing group to ensure audits of site-specific vendors are scheduled and performed (external cGMP audits of raw material, packaging component and printed product vendors, suppliers and distributors as well as contract manufacturers, packagers and laboratories to compliance with FDA regulations, cGMPs, and SOPs).
• Composes and issues audit reports.
• Conducts internal compliance investigations utilizing approved protocols as applicable.
• Follow-up on internal and external audit action items as well as FDA commitments to ensure timely completion.
• Conducts internal cGMP audits for quality assurance functions.
• Participates in the resolution of issues found during audits in conjunction with quality assurance, manufacturing, regulatory affairs and research and development functions.
• Assists in FDA inspections and third party audits.
• Assists in preparing audit protocols as needed for internal compliance investigations or for cause audits.
• Researches current and developing regulations and attends training programs.
• Ensures project deadlines and performance standards are established and met.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Develops implementation plans for new and changed corporate policies.
• Reviews information and documentation to determine compliance to standards (i.e. consultant’s qualifications, computer software vendor’s surveys, and manufacturer’s compliance review).
• Performs related duties as assigned.
Job Requirements:
Qualifications: Two (2) to four (4) years pharmaceutical Quality Control, Quality Assurance or manufacturing experience, of which one (1) year includes pharmaceutical auditing. ASQ Quality Auditor certification and FDA Investigator work experience preferred.
Education: Bachelor’s Degree in Science from an accredited college or university. An equivalent combination of education and experience may be substituted.
This is a leading specialty pharmaceutical company that uses innovative science and market insight to develop responsive products for a changing world. Their global infrastructure and extensive internal research and development capabilities provide support and growth for their three operating divisions.
Contact Information:
| Contact Name: Camley Hitti |
Company Type: |
| Company: |
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| City: Clinton |
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| State: New York |
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| Zip: 13323 |
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Web Site: http://www.grnutica.com
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