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Compliance Employment Opportunities
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Independent Contractor GCP Auditors
Responsible for Good Clinical Practice (GCP) audits of study sites, CROs, and/or IRBs. Minimum qualifications include: |
- Bachelors degree (BA/BS) preferably in biological or medical sciences
- A minimum of three years experience in GCP auditing activities and techniques;
- A solid understanding of Clinical Research principles and expertise in Good Clinical Practices (GCP) and FDA regulations/guidelines
- Demonstrated ability to work in a team environment
- Ability to travel to conduct audits
- Effective interpersonal skills; ability to work with all levels of personnel
- Effective oral and written communication skills
- Attention to detail, accuracy and completeness
- Strong computer skills (MS Word/PowerPoint/Excel)
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Independent Contractor CGMP Auditors
Responsible for Good Manufacturing Practice (GMP) audits of manufacturing facilities. Minimum qualifications include: |
- Bachelors degree (BA/BS) preferably in biological or medical sciences, chemistry or related disciplines, or engineering
- A minimum of ten years experience in Current Good Manufacturing Practices (CGMP) auditing activities and techniques
- A solid understanding of CGMP and expertise in Current Good Manufacturing Practices (CGMP) and FDA regulations/guidelines
- Demonstrated ability to work in a team environment
- Ability to travel to conduct audits
- Effective interpersonal skills; ability to work with all levels of personnel
- Effective oral and written communication skills, ability to communicate issues accurately and precisely
- Attention to detail, accuracy and completeness
- Strong computer skills (MS Word/PowerPoint/Excel)
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Independent Contractor GLP Auditors
Responsible for Good Laboratory Practice (GLP) audits of clinical and non-clinical labs. Minimum qualifications include: |
- Bachelor’s degree (BS/BA) preferably in biology, chemistry, or other scientific field.
- A minimum of three years experience in GLP auditing activities and techniques
- A strong working knowledge of Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) Good Laboratory Practice (GLP) regulations, Organization for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice, and industry standards as they apply to the life sciences and pharmaceutical industries
- Demonstrated ability to work in a team environment
- Ability to travel to conduct audits
- Effective interpersonal skills; ability to work with all levels of personnel
- Effective oral and written communication skills
- Attention to detail, accuracy and completeness
- Strong computer skills (MS Word/PowerPoint/Excel)
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Independent Contractor CSV Auditors
Responsible for Computer System Validation audits. Minimum qualifications include: |
- Bachelor’s degree (BA/BS) preferably in biological or medical sciences, computer science, information technology, engineering or related disciplines.
- A strong working knowledge of GxP regulations, guidelines, and industry standards as they apply to computer systems used within the life sciences, pharmaceutical and medical device industries
- Strong knowledge of the software development lifecycle and computer system validation (CSV) practices as they apply to the life sciences, pharmaceutical and medical device industries and ability to apply IEEE standards for software development and programming
- A solid foundation of knowledge in Quality Assurance and Quality Management principles with at least 5 years experience as a quality assurance auditor in clinical research and computer systems validation
- Working knowledge of the software systems commonly used in the industry including but not limited to Clinical Data Management, Laboratory Information and Management, Pharmacovigilence, Change Control, Bug Tracking, Interactive Voice Response, Electronic Data Capture, Systems Applications and Products (SAP)
- Basic mathematical / statistical skills
- Effective organizational and analytical skills
- Ability to work independently, in a team environment
- Effective interpersonal skills; ability to work with all levels of personnel, including technical scientists
- Effective oral and written communication skills
- Attention to detail, accuracy and completeness
- Strong computer skills (MS Word/PowerPoint/Excel)
If you are interested in any of these positions, send a copy of your curriculum vitae and rate requirements to:
Human Resources Department
Polaris Compliance Consultants, Inc.
200 Commonwealth Court, Suite 101
Cary, NC 27511 |
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200 Commonwealth Court, Suite 101 
