Clinical Quality Assurance Auditor III - Site Audits(Virtual/Home-based)
Clinical Quality Assurance Auditor III
Spanish Bilingual Preferable but Not Required(Write, Read, Conversational)
Location: Anywhere in the U.S(virtual / home-based) or any PPD office location if desired.
Travel: Travel Required(40-60%)
Responsibilities:
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 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.
Additional audits to include database, CSR, ETMF, various vendors and government trial sites.
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' for QA II and 5 for QA III level) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
Conducts and/or leads a variety of client, internal or GCP audits and regulatory inspections as requested by senior management
Leads directed site audits, facility, vendor and/or sub-contractor audits
Provides GCP 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 (e.g. database audits, clinical study report audits, sample results tables, process improvement)
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
Provides mentorship and guidance to junior auditors
Candidates with pre-inspection and inspection FDA audits are preferred.
Candidates with government audit and trial experience are highly preferred. BARDA, DAIDS, US Army, NIH, FDA, CDC, etc.
Working Conditions:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Physical Demands:
Frequently stationary for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
QA, QC, Quality Assurance, GCP, GxP, Auditing, Clinical Audit, Clinical Auditor, Quality Control, ASQ, Six Sigma, CQA, CCSGB, NIH, Virtual, Remote, Traveling auditor
IndeedPPDUS1
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Spanish Bilingual Preferable but Not Required(Write, Read, Conversational)
Location: Anywhere in the U.S(virtual / home-based) or any PPD office location if desired.
Travel: Travel Required(40-60%)
Responsibilities:
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 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.
Additional audits to include database, CSR, ETMF, various vendors and government trial sites.
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' for QA II and 5 for QA III level) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
Conducts and/or leads a variety of client, internal or GCP audits and regulatory inspections as requested by senior management
Leads directed site audits, facility, vendor and/or sub-contractor audits
Provides GCP 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 (e.g. database audits, clinical study report audits, sample results tables, process improvement)
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
Provides mentorship and guidance to junior auditors
Candidates with pre-inspection and inspection FDA audits are preferred.
Candidates with government audit and trial experience are highly preferred. BARDA, DAIDS, US Army, NIH, FDA, CDC, etc.
Working Conditions:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Physical Demands:
Frequently stationary for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
QA, QC, Quality Assurance, GCP, GxP, Auditing, Clinical Audit, Clinical Auditor, Quality Control, ASQ, Six Sigma, CQA, CCSGB, NIH, Virtual, Remote, Traveling auditor
IndeedPPDUS1
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
