PPD
Philadelphia, PA, USA
Quality Assurance Auditor II/III - Office or Home Based East Coast - Evidera - PPD's Peri and Post Approval Business Unit **Philadelphia, Pennsylvania, United States** at 6 additional locations Blue Bell, Pennsylvania, United States Bethesda, Maryland, United States Rockville, Maryland, United States Wilmington, North Carolina, United States United States Morrisville, North Carolina, United States Quality Assurance and Complian at Aug 19, 2019Post Date 1157Total Views PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. Evidera is a business unit within PPD. Evidera provides evidence-based solutions to demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products from early development through loss of exclusivity. As a Quality Assurance Auditor II/III you will conduct complex internal and external audits ensuring compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. This position offers our full benefits package as well as continued career advancement working in an office or from home within the Evidera business unit or other departments within PPD. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. Summarized Purpose: Conducts complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. May perform technical document review and other GCP/GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. Essential Functions: Conducts and/or leads a variety of client, internal or GCP/GxP audits and regulatory inspections as requested by senior management Performs directed site audits, facility, vendor and/or sub-contractor audits Provides GCP/GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audits Performs other types of QA audits or activities,this may include responsibilities for instituting and administrating systems for vendor management as well as quality systems and GCP investigations or deviations and the corrective and preventative (CAPA) action plans that result. This position may also be assigned as a QA client coordinator to coordinate, schedule and/or conduct audits for designated clients and/or Evidera-specific purposes. Serves as a resources to operational departments on audit or quality assurance subject matter Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, & experience. Successful completion of PPD Foundation Training. Knowledge, Skills and Abilities: Meets competencies for QA Auditor I plus: Thorough knowledge of GCP/GxP and appropriate regional research regulations and guidelines Demonstrated proficiency and led a range of project based or internal GCP/GxP audits and vendor audits to high standards required by management Excellent oral and written communication skills Strong problem solving, risk assessment and impact analysis abilities Solid experience in root cause analysis Above average negotiation and conflict management skills Flexible and able to multi-task and prioritize competing demands/work load Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel Management Role: No management responsibility PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel up to 20%. Additional Information + **Requisition ID: 160468**
Quality Assurance Auditor II/III - Office or Home Based East Coast - Evidera - PPD's Peri and Post Approval Business Unit **Philadelphia, Pennsylvania, United States** at 6 additional locations Blue Bell, Pennsylvania, United States Bethesda, Maryland, United States Rockville, Maryland, United States Wilmington, North Carolina, United States United States Morrisville, North Carolina, United States Quality Assurance and Complian at Aug 19, 2019Post Date 1157Total Views PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. Evidera is a business unit within PPD. Evidera provides evidence-based solutions to demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products from early development through loss of exclusivity. As a Quality Assurance Auditor II/III you will conduct complex internal and external audits ensuring compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. This position offers our full benefits package as well as continued career advancement working in an office or from home within the Evidera business unit or other departments within PPD. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. Summarized Purpose: Conducts complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. May perform technical document review and other GCP/GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. Essential Functions: Conducts and/or leads a variety of client, internal or GCP/GxP audits and regulatory inspections as requested by senior management Performs directed site audits, facility, vendor and/or sub-contractor audits Provides GCP/GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audits Performs other types of QA audits or activities,this may include responsibilities for instituting and administrating systems for vendor management as well as quality systems and GCP investigations or deviations and the corrective and preventative (CAPA) action plans that result. This position may also be assigned as a QA client coordinator to coordinate, schedule and/or conduct audits for designated clients and/or Evidera-specific purposes. Serves as a resources to operational departments on audit or quality assurance subject matter Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, & experience. Successful completion of PPD Foundation Training. Knowledge, Skills and Abilities: Meets competencies for QA Auditor I plus: Thorough knowledge of GCP/GxP and appropriate regional research regulations and guidelines Demonstrated proficiency and led a range of project based or internal GCP/GxP audits and vendor audits to high standards required by management Excellent oral and written communication skills Strong problem solving, risk assessment and impact analysis abilities Solid experience in root cause analysis Above average negotiation and conflict management skills Flexible and able to multi-task and prioritize competing demands/work load Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel Management Role: No management responsibility PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel up to 20%. Additional Information + **Requisition ID: 160468**