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.
M3 LI-ED1
Receive real-time job alerts and never miss the right job again
US - WV - WV - Halltown
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Harpers Ferry
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Millville
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Inwood
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Charles Town
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Martinsburg
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Kearneysville
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Morgantown
November 14, 2024
Travel Nurses, Inc. is seeking a travel nurse RN Med Surg for a travel nursing job in Morgantown, West Virginia. & Requirements • Specialty: • Med Surg • Discipline: • RN • Duration: • 13 weeks • 36 hours per week • Shift: • 12 hours, nights • Employment Type: • Travel We are looking for MedSurg RN...
US - WV - WV - Summit Point
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Ranson
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Martinsburg
November 14, 2024
Medical Solutions is seeking a travel nurse RN PCU - Progressive Care Unit for a travel nursing job in Martinsburg, West Virginia. & Requirements • Specialty: PCU - Progressive Care Unit • Discipline: RN • Duration: 13 weeks • 36 hours per week • Shift: 12 hours, days • Employment Type: Travel We're...
US - WV - WV - Bakerton
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Shenandoah Junction
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Shepherdstown
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Hilltop
November 14, 2024
Healthcare Support is seeking a travel Speech Language Pathologist for a travel job in Hilltop, West Virginia. & Requirements • Specialty: Speech Language Pathologist • Discipline: Therapy • Start Date: 12/09/2024 • Duration: 13 weeks • 40 hours per week • Shift: 8 hours • Employment Type: Travel...
US - WV - WV - Huntington
November 14, 2024
Core Medical Group is seeking a travel nurse RN PACU - Post Anesthesia Care for a travel nursing job in Huntington, West Virginia. & Requirements • Specialty: PACU - Post Anesthesia Care • Discipline: RN • Start Date: 12/02/2024 • Duration: 13 weeks • 36 hours per week • Shift: 12 hours • Employment...
US - WV - WV - Morgantown
November 14, 2024
MedPro Healthcare Staffing is seeking a travel nurse RN PCU - Progressive Care Unit for a travel nursing job in Morgantown, West Virginia. & Requirements • Specialty: PCU - Progressive Care Unit • Discipline: RN • Start Date: 11/28/2024 • Duration: 13 weeks • 36 hours per week • Shift: 12 hours,...
US - WV - WV - Charleston
November 10, 2024
Certification Details • Certs Required: BLS; MAB Preferred • Skill Requirements: IV Start, Telemetry, PCU/IMC • Special Procedures: Ostomies, Chest Tubes, Wound Vacs/Care, CPAP/BiPAP, Central Lines, PICCs, Drips (Heparin, Amnio, Cardizem, Cardiac Drips) Job Details • 3S CV Telemetry RN • 3x12 or...
US - WV - WV - Salem
November 14, 2024
Ardor Health Solutions is seeking a travel Physical Therapist for a travel job in Salem, West Virginia. & Requirements • Specialty: Physical Therapist • Discipline: Therapy • Start Date: 01/20/2025 • Duration: 13 weeks • 40 hours per week • Shift: 8 hours, days • Employment Type: Travel • Location:...
US - WV - WV - Ridgeway
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Huntington
November 14, 2024
Care Team Solutions is seeking a travel nurse RN PACU - Post Anesthesia Care for a travel nursing job in Huntington, West Virginia. & Requirements • Specialty: PACU - Post Anesthesia Care • Discipline: RN • Start Date: 12/02/2024 • Duration: 13 weeks • 36 hours per week • Shift: 12 hours •...
US - WV - WV - Bunker Hill
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Huntington
November 14, 2024
Supplemental Health Care is seeking a travel nurse RN PACU - Post Anesthesia Care for a travel nursing job in Huntington, West Virginia. & Requirements • Specialty: PACU - Post Anesthesia Care • Discipline: RN • Start Date: ASAP • Duration: 13 weeks • 36 hours per week • Shift: 12 hours, nights •...
US - WV - WV - Charleston
November 14, 2024
Core Medical Group is seeking a travel nurse RN Long Term Acute Care for a travel nursing job in Charleston, West Virginia. & Requirements • Specialty: Long Term Acute Care • Discipline: RN • Start Date: 12/02/2024 • Duration: 13 weeks • 36 hours per week • Shift: 12 hours • Employment Type: Travel...
US - WV - WV - Falling Waters
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...
US - WV - WV - Summersville
November 14, 2024
Healthcare Support is seeking a travel nurse RN Home Health for a travel nursing job in Summersville, West Virginia. & Requirements • Specialty: Home Health • Discipline: RN • Start Date: 12/14/2024 • Duration: 13 weeks • 40 hours per week • Shift: 8 hours • Employment Type: Travel RN Home Health •...
US - WV - WV - Rippon
November 13, 2024
About the Job: • Monitor patients throughout their treatment. • Perform routine checks of patients' vital signs. • Ensure that patients take their medication. • Assist doctors and registered nurses. • Liaise with patients' families. • Qualifications: • LPN state...