Compliance Career Opportunities

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, chemistry, or related discipline
• A minimum of three years experience in GCP auditing activities and techniques
• A solid understanding of Clinical Research principles and expertise in FDA GCP regulations/guidances and ICH GCP Guidelines (experience with 21 CFR Part 11, GCLP, or international regulatory agencies a plus)
• Demonstrated ability to work both independently and 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 Microsoft Office skills
• Strong industry-specific application skills (eCRF, eTMF, EMR, IxRT, etc.)

GCP SOP Writers

Responsible for conducting gap analyses on existing SOPs and prepare new SOPs. Minimum qualifications include:

• A minimum of five years experience with GCP practices and processes
• Experience writing SOPs for CROs, biopharmaceutical, medical device, or nutraceutical companies
• A solid understanding of Clinical Research principles and expertise in FDA GCP regulations/guidances and ICH GCP Guidelines
• Experience with flow charting processes for writing effective procedures
• Ability to travel to occasional client meetings, if needed
• Effective interpersonal skills; ability to work with all levels of personnel
• Exceptional written communication skills
• Effective communication skills; ability to communicate issues accurately and precisely
• Attention to detail, accuracy, completeness, and timelines
• Strong Microsoft Office skills
• Ability to multi-task

Independent Contractor CGMP Auditors

Responsible for Good Manufacturing Practice (GMP) audits of manufacturing facilities. Minimum qualifications include:

• Bachelors degree (BA/BS) preferably in engineering, biological or medical sciences, chemistry, or related discipline
• A minimum of ten years experience in Current Good Manufacturing Practices (CGMP) auditing activities and techniques
• A minimum of five years experience vendor/supplier and finished product auditing
• A minimum of five years internal auditing experience
• A solid understanding of manufacturing principles and expertise in FDA CGMP regulations/guidelines and ICH CGMP Guidelines (experience with 21 CFR Part 11 and international regulatory agencies a plus)
• 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)

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 related discipline
• A minimum of three years experience in GLP auditing activities and techniques
• A strong working knowledge of FDA and EPA GLP regulations/guidelines, OECD Principles of Good Laboratory Practice (experience with GCLP a plus)
• 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)

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 discipline
• A strong working knowledge of GxP regulations (including 21 CFR Part 11), 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 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, Pharmacovigilance, Change Control, Bug Tracking, Interactive Voice Response, Electronic Data Capture, and Systems Applications and Products (SAP)
• Basic mathematical / statistical skills
• Effective organizational and analytical skills
• Demonstrated ability to work in a team environment
• Effective interpersonal skills; ability to work with all levels of personnel, including technical scientists
• 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)
   

If you are interested in any of these positions, email us your curriculum vitae and rate requirements to
info@polarisconsultants.com.