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Title: Third Party SUPPLIER QUALITY SPECIALIST
Summary: Under general supervision, maintains, collects and performs data entry to support systems and processes to ensure compliance with cGMP and FDA requirements within Third Party Quality.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
• Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Process Product Quality Complaints and supporting information/documents accurately and timely via related department system software such as Argus, and Trackwise.
• Request and track Annual Stability batch information
• Complete information / documentation requests, receipt, distribution and filing in support of assigned projects
• Assist with data entry into Trackwise system in support of Third Party Quality activities
• Perform Administrator duties for TPQ SharePoint Site such as granting/removing access, trouble shooting and general site maintenance.
• Review and ensure the validity of information, data, documentation, and records received from third party manufacturers.
• Support of training coordination activities including assignment of roles and curricula
• Complete assigned activities, prepare reports and communicate with internal and external contacts.
• Create, update and provide feedback on departmental procedures as necessary to meet cGMP and departmental requirements and assist with documentation management in electronic system.
• Assure compliance with all Company policies and procedures, including safety rules and regulations.
• Perform related duties as assigned.
Required Knowledge and Skills:
• cGMP and Food and Drug Administration regulations and requirements.
• Business computer applications, such as Microsoft Word and Excel.
• Trackwise and Argus
• Business English usage, spelling, grammar and punctuation.
• Communicating clearly and concisely, both orally and in writing.
• Attention to detail in gathered data and information.
• Managing multiple duties and assignments.
• Establishing and maintaining cooperative working relationships with others.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of attending to detail, sitting, standing and walking, viewing computer monitors and typing using keyboards, lifting boxes weighing up to 25 pounds and moderate noise levels. Work is performed in office environment.
Minimum Qualifications: College Degree and a minimum of one (1) to two (2) years of pharmaceutical quality assurance experience; or equivalent combination of education and experience.
Rockaway, NJ-USA (until mid-November 2017) and then Madison, NJ-USA
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