Quality Support

Quality Support
Tarrytown, NY
12 months extendable contract (potential to convert fulltime)


The Quality Support, Complaint Trending, position is responsible for the monitoring and trending of open and closed customer complaints for Laboratory Diagnostic (LD) products through the entire product life cycle. This role will develop and validate dashboards in SAS Visual Analytics or QlikView applications, utilize SAS Enterprise to aggregate and analyze complaint trending data using validated programs. The role will further advise on statistical techniques for trending and analysis of complaint data.
This role will serve as a point of contact across multiple functions (quality, statistics, customer service) for trending activities in the LD business area. The role will interact closely with these functions to drive process development and continuously drive process improvements in the areas of monitoring and trending complaints.
A balance of both analytical and communications skills is crucial for the role. In addition to trending analytics, the role will interface across multiple sites and functions to understand trending requirements, develop and implement appropriate tools and statistical methodology, conduct training, and address questions from internal and external stakeholders and competent authorities.
This is a unique role for someone with experience that bridges statistical analysis of data and quality assurance.
The position will report to the Director of Statistical Affairs within Medical, Statistical, and Scientific Affairs (MSSA).

Responsibilities
• Analyze complaint trending data using SAS and make conclusions regarding observed trends.
• Develop and validate complaint trending dashboards in SAS Visual Analytics or QlikView applications.
• Maintain documentation on SAS programs and dashboards used in Complaint Trending.
• Support complaint escalation process to Product Health Team/PLM through data collection and analysis activities.
• Provide support to internal and external audits
• Develop and extend statistical methodologies and application tools to identify adverse complaint trends.
• Discuss adverse trends that should be escalated for additional investigation. Provide support to these investigations through the retrieval and statistical analysis of complaint data.
• Ensure analysis codes are properly assigned to field events in the complaint handling system. Where appropriate, provide recommendations to improve the event coding process.

Required Knowledge/Skills, Education, and Experience
• Minimum educational background of BS in statistics/biostatistics, engineering, chemistry, biology, or other quantitative field.
• 5 years of experience, preferably in medical diagnostics or pharmaceutical industries.
• Experience with the analysis of data and development of reports in SAS/SAS Visual Analytics or QlikView is required.
• Knowledge of software validation, statistical programming in SAS, and statistical techniques.
• Experience with trending and analysis of complex data from multiple source preferably within the context of post-market quality surveillance
• Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems.
• Ability to work independently and in project teams.
• Excellent communication skills (written and spoken)
• This position will be located in Tarrytown, NY

Thanks & Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
510-402-4704 (Voice & Text)
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com 
linkedin.com/in/imranshikalgar

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