QA/Regulatory Spec II
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POST DATE 8/6/2020
END DATE 8/13/2020
JOB DESCRIPTIONJOB OVERVIEW:
This position is office based in Dallas. As a member of our QA team for Phase I you will be responsible for hosting client audits, interacting with health authority and acting as a SME to represent the company.
* Coordinates preparations for, and participates in regulatory inspections when requested.
* Act as an expert on broad based routine (day-to-day) regulatory compliance issues, and provide guidance to teams in areas of regulatory compliance.
* Interprets GCPs, applicable GLPs, and cGMPs and associated regulatory documents to facilitate auditing and process improvement recommendations.
* Audits protocols, phases of clinical studies, reports, and performs related duties (e.g. schedules studied/inspections, issues QA statements) to ensure regulatory compliance.
* Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Data Services, IRB, Archives, Vendor and Facility Audits).
* Writes and issues inspection reports. Works with internal customers to ensure that inspection findings are clearly communicated and understood. Evaluates inspection-finding responses to ensure they are written to address the findings appropriately.
* Ensures through process and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced.
* Identifies and communicates opportunities for process improvement based on audit and inspection observations. Participates in and guides process improvement activities in both small intradepartmental group as well as complex and possible multi-departmental interactions.
* Is able to present in small group training on specific GCP topics.
* Mentors less experienced auditors.
* Notifies management of observed quality and compliance trends in the areas inspected.
* Recommends modifications in procedures to fit special needs or problems and involves supervisor when assistance in process improvement/resolution is necessary.
* Schedules and coordinates work with study project teams and supervisor/peers in Quality Assurance.
* Performs other related duties as assigned.
* Bachelor of Science/Arts (BS/BA) degree, preferred in a science related field.
* Demonstrated competencies in quality assurance practices and regulatory compliance knowledge.
* Proficient in use of computer and Microsoft software programs (e.g., Word and Excel).
* Minimum of 5 (five) years experience in the pharmaceutical/CRO industries, with at least 1 (one) year in Clinical Quality Assurance, preferably within a GCP environment.
* Ability to effectively interact with Clinical Pharmacology, CDARO, and ECD management and scientific staff. Ability to independently negotiate, provide constructive feedback, and support process improvement initiatives.
* Skilled in both verbal and written communication to effectively communicate and negotiate.
* Additional experience may be substituted for education requirements.