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PrintQA Associate III
| Company: | Covance Company Profile | Current Opportunities (7) |
| Job Location(s): | Dallas |
| Employment Term: | Regular |
| Employment Type | Full Time |
| Start Date: | As soon as possible |
| Starting Salary Range: | Not Provided |
| Required Education: | Associate Degree |
| Required Experience: | Open |
| Related Categories: | Quality Assurance/Safety |
Position Description
| QA Associate III | |
| 21669BR | |
| Quality | |
| USA - Dallas, TX | |
| 1 | |
| Covance is a leading supplier of drug development services to the biotechnology and pharmaceutical industries. We partner with innovative companies, offering valuable services in all phases of the drug development process as well as analytical and commercial impact services. As an integral part of these partnerships, our employees make a difference in the lives of millions. Before drugs, chemicals or foods can be sold, they must be evaluated for safety and effectiveness. Covance provides international testing services to clients in the pharmaceutical, food, biotechnology and chemical services industries. Quality Assurance in Covance’s Phase I Clinical Development Services Business is growing! We are looking for individuals with GCP auditing experience. A QA Associate III, audits study conduct, protocols, data and reports for compliance with appropriate SOPs, GCPs, and other regulatory requirements in multiple disciplines. They also Initiate and facilitate quality improvement objectives throughout the organization and host client visits and provide support in hosting regulatory inspections. In addition, they are looked to as mentors for less experienced staff. Additional duties and responsibilities include: 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 phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced. Is able to present in small group training on specific GCP topics. Maintains necessary documentation of QA records and study files. 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. Act as an expert on broad based regulatory compliance issues. Schedules and coordinates work with study project teams and supervisor/peers in Quality Assurance. Provides a monthly review of activities to the QA Manager. | |
| Bachelor of Science/Arts (BS/BA) degree, preferred in a science related field. Proficient in use of computer and Microsoft software programs (e.g., Word and Excel). Ability to effectively interact with CRU pharmacometrics, management and scientific staff. Ability to negotiate, provide constructive feedback and support process improvement initiatives. Ability to travel up to 30% of the time. Skilled in both verbal and written communication. | |
| A minimum of 3 years of experience as a Clinical Quality Auditor. Additional experience may be substituted for education requirements. | |
| 5 |
