Associate Quality Control Auditor
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Job Location:
Prague - Czech Republic
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Ensures the quality and integrity of data and information by conducting timely and cost effective audits of diverse scope against customer sponsor PPD and regulatory requirements and specifications. May provide review services for CDS Biostatistics and Data Management Regulatory Affairs Phase I or any other PPD department as requested.
Day to day responsibilities:
Conducts document reviews which may include but not be limited to reviews of protocol case report forms case report form guide investigators brochure investigator files monthly reports clinical/statistical reports Phase I reports statistical reports abstracts manuscripts or miscellaneous study tools) that concentrate on key measures operational standards and sponsor requirements to ensure accuracy consistency and integrity of data/information
Conducts reviews of subject source data prior to enrollment and subject source data/CRF entry prior to database lock to archive submission to ensure completeness and accuracy of files
Prepares written audit reports that accurately describe audit findings
Communicates specific findings questions and/or concerns in a timely fashion. Maintains audit trail of decisions or changes.
Interacts with PM when needed to effectively communicate QC project needs problems and timeframes for completion. Participates in team meetings as requested
Assists in the development/revision of procedural documents as appropriate
Provides resource/training for team members and/or personnel in the QC process
Performs other job related duties as assigned
Qualifications:
Education and Experience: Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 0 to 2 years). In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills and Abilities:
Working knowledge of FDA regulations and guidelines Good Clinical Practices and PPD SOPs/Working Practice Documents
Computer skills including Microsoft Office and database entry
Must have the ability to analyze and interpret data
Detail oriented
Independent judgment and good decision making capabilities
Good oral and written communication skills
Good interpersonal skills
Must be able to function in the role of mentor/trainer for ongoing process improvement issues with the study teams
Time management and project management skills
Ability to work in a collaborative team environment
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Physical Requirements:
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
Required Experience:
IC
Key Skills
- Quality Assurance
- Quality Inspection
- Calipers
- ISO 9001
- Quality Audits
- Process Mapping
- Fair Housing Regulations
- Quality Control
- Underwriting
- cGMP
- As9100
- Manufacturing
About Company
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