Corporate Records Manager
Job Type:
Regular Full-Time
Location:
Seattle, WA
Job Description:
Dendreon is seeking a dynamic Corporate Records Manager who will work at the enterprise level of our organization to manage the active, inactive, and vital records processes. The successful candidate will have an understanding of electronic records managements systems and possess extensive knowledge of design, creation, implementation, and management of records, and experience in the management of records department staff.
General Summary:
Performs a wide variety of activities which may include one or more of the following:
Develops, communicates and manages the processes for the retention and retrieval of corporate records to comply with various laws and regulations that govern the storage of paper and electronic records such as the Health Insurance Portability and Accountability Act (HIPAA), Sarbanes-Oxley Act (SOX), Code of Federal Regulations (CFR), and FDA Good Manufacturing Practices (GMPs).
Meets the various records retention needs for all department with a focus on service including:
Maintains database for retrieval of off-site Corporate Records.
Maintains scientific laboratory notebook tracking for compliance.
Coordinates with internal departments and external vendors.
Provides company-wide employee training for document retention, destruction, data migration and legal liability compliance.
Manages relationships with records storage vendors to enhance the use of current technology, track facilities, inventories, and payments.
Supports the Legal department for attorney matters (e.g. in response to subpoenas).
Job Requirements:
Bachelor’s degree in library sciences or equivalent.
Typically 5 years related experience in cGMP/FDA regulated industry; 2 years of leadership.
Knowledge of cGMP/ICH/FDA regulations.
Certifications are a plus (Certified Records Manager, ERM Master, ECM Master, etc.).
Proficient in MS Office, OmniRim and ERM experience are a plus.
Working Conditions and Physical Requirements:
Must be able to lift and move standard size archive boxes, e.g. 30-40 lbs boxes.
Minimal travel may be required.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.