Job Title: Senior Technical Information Specialist
Security Clearance Required: Federal Background Investigation
Work Location: Silver Spring, MD
Position Overview: The Senior Technical Information Specialist will be responsible for analyzing regulatory documents.
Shearwater Systems, LLC is a Mission Support Services and Facility Support Services company providing support to government and commercial entities. Shearwater is an 8(a) Program certified, Alaska Native Corporation (ANC)-owned, Small Disadvantaged Business (SDB). We are a subsidiary of Three Saints Bay, LLC, which is owned by Old Harbor Native Corporation. Our Corporate Headquarters is located in Anchorage, AK and our Operational Office is in Manassas, VA.
POSITION RESPONSIBILITIES:
SCOPE:
The scope of this contract entails operation, management, and support of FDA onsite document, records and information management related activities. Support encompasses records lifecycle activities, quality control, DCC management, storage services, onsite DCC scanning, training, metadata management, and records management.
Records include regulatory, administrative, and program materials that support the agency’s business functions. Business functions of the FDA pertain to human and animal pharmaceutical and biological drugs, scientific research, food safety, medical devices, and public health issues.
Specific Responsibilities:
• The Senior Technical Information Specialist is responsible for analyzing scientific regulatory documents.
• Performs quality control on processed documents and completes daily log of all submissions.
POSITION REQUIREMENTS:
• Ability to pass a Federal Background Investigation.
• Bachelor’s in Science or Information Management
• Proficient in reading, analyzing, classifying, and interpreting regulatory submissions.
• Ability to lead special project teams is preferred, with a minimum of three (3) years of increasingly responsible experience in records and document management required.
• Experience with scientific regulatory documents, and demonstrated speaking, writing, and demonstrated customer service skills.
• In‐depth background with computer use, including a working knowledge of the standard Microsoft suite of products.
• Experience in areas such as quality control, overseeing document tracking databases, inventorying records, scanning, and micrographics.
• Ability to implement SOPs and train staff in their use.
VEVRAA Federal Contractor
Three Saints Bay, LLC and its subsidiaries offer a diverse, team-oriented working environment and the opportunity to work with exceptional dedicated industry professionals. We offer our employees a comprehensive benefits package and the opportunity to take part in exciting projects with government and commercial clients, both domestic and international.
We are an EEO/AA employer. We invite resumes from all interested parties without regard to race, color, religion, creed, gender, national origin, age, genetic information, marital or veteran status, disability, or any other category protected by federal, state, or local law.
Reference : Senior Technical Information Specialist – 944 jobs
Source: http://jobrealtime.com/jobs/technology/senior-technical-information-specialist-944_i6175
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