Quality Auditor job in Tampa, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Quality Auditor for a leading biopharmaceutical company located in Tampa, FL. The Data Quality Auditor is responsible for developing and improving data organization and output, reviewing existing processes and suggesting new approaches and practices ensuring that our published data is at all times accurate.

Job Responsibilities:

Train Research and Process Development new hires or staff as needed on how to conduct a data audit or survey of data and how to write a formal data audit report. File all training records in binder.
Conduct "kick- off" meetings with team members when data is submitted for audit to discuss data sets, what Is needed for audit, audit strategy, and key risks involved.
Perform Data Audit per SOP procedure on all published data from Process Development projects to ensure all data is being collected, converted, and processed correctly.
Conduct meetings with data originators upon finding any errors or concerns during audit to discuss discrepancies and action items. Collect corrected proof from data originators.
File all Audit Reports and make sure Audit Reports are attached to Study Reports in Master Control Document System.
Perform Spreadsheet Qualifications as needed.
Perform data entry for Process Data into master Spreadsheet as needed.
In addition to PD, provide support to MSAT, Translational, and Research Teams as needed for Data Audit, Investigation events, etc.
Support Regulatory as needed for QC checks of submission sections.

Skills and Requirements:

Bachelor's or Master's degree (B.S./B.A./M.S.) or equivalent, preferably in a life science or STEM related discipline
Previous data Analysis Experience is preferred
Proficiency in Microsoft Office Suite and spreadsheet programs required
Proficiency in graphing and statistical software is desirable
Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings
Strong interpersonal, written, and oral communication skills are required
Must be organized, be able to multi task, and be a team player

If you are having difficulty in applying or if you have any questions, please contact Christian Delbaere at (+1) 347-227-1672 or c.delbaere@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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