Senior GMP Auditor
Share
Job Location:
Sparta, TN - USA
Monthly Salary:
$ 90 - 100
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
This is a 1099 Contract opportunity with no benefits. Pay rate is $90-$100/hr.
This is a remote role with occasional travel to our clients sites across the US.
Job Description
Senior GMP Auditor
CDMO Manufacturing and Clinical Packaging Site (United States)
Position Overview
Our organization is seeking a highly experienced Senior GMP Auditor with deep expertise in pharmaceutical manufacturing and clinical packaging operations. This role will perform a comprehensive independent audit of a CDMO manufacturing and clinical packaging facility located in the United States. The auditor will focus on the strength and effectiveness of key quality systems clinical packaging and labeling controls and overall GMP compliance that supports clinical trial material supply.
Key Responsibilities
Site Audit Leadership
Plan lead and execute a full scope GMP audit of the CDMO manufacturing and clinical packaging site.
Evaluate the design implementation and effectiveness of core quality systems including deviation management investigations CAPA change control complaint handling batch record management and document control.
Review training systems for operations quality and support personnel with attention to role-based qualification and ongoing GMP training.
Assess data integrity and data governance practices across paper and electronic systems that support manufacturing testing and release.
Clinical Packaging and Labeling Oversight
Perform a detailed audit of clinical packaging operations including labeling kitting packaging component controls storage conditions and distribution interfaces.
Evaluate control of printing reconciliation and verification activities for labels and patient specific or blinded clinical supplies.
Review environmental monitoring temperature and humidity controls and segregation practices for clinical trial materials.
Confirm that packaging labeling and associated documentation provide adequate control to support complex clinical trial designs randomization schemes and blinding requirements.
Quality System and Compliance Assessment
Assess the overall maturity and effectiveness of the site quality management system including governance quality metrics and management review.
Review supplier and service provider qualification processes relevant to manufacturing and clinical packaging.
Evaluate investigation quality root cause analysis and effectiveness checks for deviations and complaints related to packaging and manufacturing.
Identify compliance gaps systemic weaknesses and areas where risk to product quality or patient safety may exist.
Reporting and Follow Up
Prepare a clear detailed written audit report that documents observations evidence and associated risk levels.
Provide practical prioritized recommendations for corrective and preventive actions that align with GMP expectations.
Present key findings and risk themes to site leadership and client stakeholders in a professional objective manner.
Support follow up discussions related to remediation plans timelines and verification of effectiveness as requested.
Required Experience
Minimum of fifteen years of GMP experience in pharmaceutical manufacturing clinical packaging or quality assurance with significant time spent in auditing roles.
Demonstrated experience conducting comprehensive audits of manufacturing and clinical packaging operations at CDMO or large pharmaceutical sites.
Strong working knowledge of United States FDA regulations ICH guidelines and current industry expectations for clinical trial material manufacturing and packaging.
Deep familiarity with quality systems that support clinical packaging including label control reconciliation randomization support chain of custody and documentation practices.
Proven ability to independently evaluate the maturity and robustness of complex quality systems and to distinguish between isolated issues and systemic risks.
Excellent written and verbal communication skills with a track record of producing clear defensible audit reports and communicating with senior stakeholders.
Additional Requirements
Ability to travel to and work on site at the CDMO facility in the United States.
Strong professional presence objectivity and sound judgment when interacting with site leadership and functional teams.
Ability to manage the audit scope and timeline efficiently while maintaining depth and quality of assessment.
This is a remote role with occasional travel to our clients sites across the US.
Job Description
Senior GMP Auditor
CDMO Manufacturing and Clinical Packaging Site (United States)
Position Overview
Our organization is seeking a highly experienced Senior GMP Auditor with deep expertise in pharmaceutical manufacturing and clinical packaging operations. This role will perform a comprehensive independent audit of a CDMO manufacturing and clinical packaging facility located in the United States. The auditor will focus on the strength and effectiveness of key quality systems clinical packaging and labeling controls and overall GMP compliance that supports clinical trial material supply.
Key Responsibilities
Site Audit Leadership
Plan lead and execute a full scope GMP audit of the CDMO manufacturing and clinical packaging site.
Evaluate the design implementation and effectiveness of core quality systems including deviation management investigations CAPA change control complaint handling batch record management and document control.
Review training systems for operations quality and support personnel with attention to role-based qualification and ongoing GMP training.
Assess data integrity and data governance practices across paper and electronic systems that support manufacturing testing and release.
Clinical Packaging and Labeling Oversight
Perform a detailed audit of clinical packaging operations including labeling kitting packaging component controls storage conditions and distribution interfaces.
Evaluate control of printing reconciliation and verification activities for labels and patient specific or blinded clinical supplies.
Review environmental monitoring temperature and humidity controls and segregation practices for clinical trial materials.
Confirm that packaging labeling and associated documentation provide adequate control to support complex clinical trial designs randomization schemes and blinding requirements.
Quality System and Compliance Assessment
Assess the overall maturity and effectiveness of the site quality management system including governance quality metrics and management review.
Review supplier and service provider qualification processes relevant to manufacturing and clinical packaging.
Evaluate investigation quality root cause analysis and effectiveness checks for deviations and complaints related to packaging and manufacturing.
Identify compliance gaps systemic weaknesses and areas where risk to product quality or patient safety may exist.
Reporting and Follow Up
Prepare a clear detailed written audit report that documents observations evidence and associated risk levels.
Provide practical prioritized recommendations for corrective and preventive actions that align with GMP expectations.
Present key findings and risk themes to site leadership and client stakeholders in a professional objective manner.
Support follow up discussions related to remediation plans timelines and verification of effectiveness as requested.
Required Experience
Minimum of fifteen years of GMP experience in pharmaceutical manufacturing clinical packaging or quality assurance with significant time spent in auditing roles.
Demonstrated experience conducting comprehensive audits of manufacturing and clinical packaging operations at CDMO or large pharmaceutical sites.
Strong working knowledge of United States FDA regulations ICH guidelines and current industry expectations for clinical trial material manufacturing and packaging.
Deep familiarity with quality systems that support clinical packaging including label control reconciliation randomization support chain of custody and documentation practices.
Proven ability to independently evaluate the maturity and robustness of complex quality systems and to distinguish between isolated issues and systemic risks.
Excellent written and verbal communication skills with a track record of producing clear defensible audit reports and communicating with senior stakeholders.
Additional Requirements
Ability to travel to and work on site at the CDMO facility in the United States.
Strong professional presence objectivity and sound judgment when interacting with site leadership and functional teams.
Ability to manage the audit scope and timeline efficiently while maintaining depth and quality of assessment.
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @. If you receive a message that seems suspicious or is not from our official domain please report it immediately to
Required Experience:
Senior IC
Key Skills
- Auditing
- Accounting Software
- Data Analytics
- GAAP
- Accounting
- Analysis Skills
- SOX
- Financial Analysis
- Financial Report Interpretation
- Internal Audits
- Mentoring
- GAAS
About Company
Home - The Industry Recognized Leader in Quality & Compliance Consulting, Validation Consilting, Staffing & More.
