US - Kentucky - Monticello
November 12, 2024
Job Title:
QA Consultant (GCP Compliance) Location:
Remote with potential travel to company sites as needed.
Hours/Schedule:
20hrs/wk for first few months, then transitioning to 40hours/wk as time goes on Compensation:
Open to discuss, depending on experience Contract Length:
3-6 months, with potential for extension based on project needs.
Overview:
We are seeking an experienced QA Consultant to assist a biotech company in preparing for an FDA audit with a strong focus on Good Clinical Practice (GCP) compliance.
The ideal candidate will have a deep understanding of GCP regulations and extensive experience guiding companies through FDA submission readiness, ensuring documentation, processes, and practices meet all regulatory requirements.
Key Responsibilities:
Reviewing GCP operations and documentation to support regulatory filing (NDA submission) Supporting inspection readiness by assessing compliance with site, sponsor and provider (eclinical companies, biorepositories, clinical labs) Assess current QA processes and documentation for GCP compliance.
Identify gaps and provide actionable recommendations to align with FDA requirements.
Develop and implement SOPs, training programs, and corrective actions as needed.
Conduct mock audits and prepare teams for potential audit scenarios.
Review clinical trial data, monitoring processes, and vendor qualifications for adherence to GCP.
Support the company in compiling and organizing audit documentation for FDA submission.
Provide guidance during the audit process and help address any findings or concerns.
Qualifications:
Bachelor's degree in Life Sciences or related field; advanced degree preferred.
Minimum of 5 years of experience in QA with a focus on GCP and FDA audits.
Proven track record of preparing small biotech or pharma companies for successful FDA inspections.
Proven examples of gap assessments performed and remediated in advance of filing and inspection Strong understanding of FDA regulations, ICH guidelines, and GCP principles.
Excellent communication skills and the ability to work effectively with cross-functional teams.
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