What are the responsibilities and job description for the Quality Compliance Auditor position at Advanced Clinical?
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Quality Compliance Auditor in Los Angeles, CA. The Quality Compliance Auditor role will perform routine GMP audits as well as specialty and technical audits in relation to current products and prospective in-license agreements, provide compliance guidance and support throughout the Quality organization, and lead multi-departmental teams and initiatives. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* To ensure success as a Quality Auditor, the candidate should possess in-depth knowledge of product standards and extensive experience as a related pharmaceutical experience preferably in manufacturing, quality assurance, or cGxP auditing and demonstrated project management experience in leading cross-functional teams.
* Prepare and execute internal self-inspections and supplier audits and issue reports.
* Follow up on post audit action tracking & progress.
* Assisting in implementing Internal Audit plans for all manufacturing plants.
* Assisting in implementing Supplier Audit plans for all manufacturing plants.
* Trends, analyses, and reports on quality data to improve product and process Quality for all plants; develop actions for improvement based on data analyses.
* Peer Review of Audits Reports.
* Provide support prior, during and post inspections for external Regulatory Inspections, Customer Audits and Corporate Internal Audits.
* Ensures the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems.
* Keeping abreast of industry standards and regulations.
* All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
* Contribution to the continuous improvement of the Quality Management System is required.
* Other additional duties may be assigned by the Director Quality Audits from time to time if required.
* Ability to travel (up to 30%)
EXPERIENCE
Minimum of 5 years related pharmaceutical experience, preferably in manufacturing, quality assurance, or cGxP auditing.
EDUCATION
Minimum of Bachelor's Degree in a scientific discipline required
ASQ Certification as a Quality Auditor, Manager, or Engineer a plus.
To be a best-fit your strengths must include:
* Strong interpersonal skills.
* Excellent written and verbal communication skills.
* Effective influence management and conflict resolution abilities.
* Highly developed investigative and reporting skills.
* Effective organization and time management skills.
* Expected to work and grow in a team-oriented environment and continue to build synergies between the Quality Audits group and internal and external quality and manufacturing groups.
* Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.
* Flexible, able to adapt quickly to change in a fast-paced environment.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
We are currently searching for a skilled professional to join a well-known client's team as a Quality Compliance Auditor in Los Angeles, CA. The Quality Compliance Auditor role will perform routine GMP audits as well as specialty and technical audits in relation to current products and prospective in-license agreements, provide compliance guidance and support throughout the Quality organization, and lead multi-departmental teams and initiatives. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* To ensure success as a Quality Auditor, the candidate should possess in-depth knowledge of product standards and extensive experience as a related pharmaceutical experience preferably in manufacturing, quality assurance, or cGxP auditing and demonstrated project management experience in leading cross-functional teams.
* Prepare and execute internal self-inspections and supplier audits and issue reports.
* Follow up on post audit action tracking & progress.
* Assisting in implementing Internal Audit plans for all manufacturing plants.
* Assisting in implementing Supplier Audit plans for all manufacturing plants.
* Trends, analyses, and reports on quality data to improve product and process Quality for all plants; develop actions for improvement based on data analyses.
* Peer Review of Audits Reports.
* Provide support prior, during and post inspections for external Regulatory Inspections, Customer Audits and Corporate Internal Audits.
* Ensures the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems.
* Keeping abreast of industry standards and regulations.
* All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
* Contribution to the continuous improvement of the Quality Management System is required.
* Other additional duties may be assigned by the Director Quality Audits from time to time if required.
* Ability to travel (up to 30%)
EXPERIENCE
Minimum of 5 years related pharmaceutical experience, preferably in manufacturing, quality assurance, or cGxP auditing.
EDUCATION
Minimum of Bachelor's Degree in a scientific discipline required
ASQ Certification as a Quality Auditor, Manager, or Engineer a plus.
To be a best-fit your strengths must include:
* Strong interpersonal skills.
* Excellent written and verbal communication skills.
* Effective influence management and conflict resolution abilities.
* Highly developed investigative and reporting skills.
* Effective organization and time management skills.
* Expected to work and grow in a team-oriented environment and continue to build synergies between the Quality Audits group and internal and external quality and manufacturing groups.
* Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.
* Flexible, able to adapt quickly to change in a fast-paced environment.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
