Kforce has a client in San Diego, CA that is seeking a Senior Document Control Specialist.Responsibilities:
Coordinating/processing product and process changes that range from simple to complex within an Electronic Data Management System
Interfacing with intra / inter - departmental associates on change management
Carrying out the daily operations of the Change Management function as it pertains to product labeling, design control projects and device master records maintenance
Works with Manufacturing, Marketing, Purchasing and Regulatory to provide an initial analysis of implementation timing, potential scrap costs and quantities of new labeling to be ordered
Assists labeling change owners and junior staff with the creation of design change plans
Updating design change logs and analyzing labeling changes for impact to Device Master Records
Able to work under minimal supervision
Excellent verbal and writing skills
Ability to handle multiple projects simultaneously and to prioritize tasks
Ability to follow detailed instructions, maintain accurate records, complete assignments in a thorough, conscientious fashion while adhering to company procedures and QSR compliance
Advanced knowledge of Microsoft Office applications (Word, Excel, PowerPoint and Visio)
Experience with Adobe Acrobat Professional
Familiar with federal and other regulations, e.g. QSR's, ISO 13485, CMDR, IVDD
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job
Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Follow all safety guidelines, manufacturing policies and procedures; Operate under QSR complianceThe pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.
We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.
Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.
This job is not eligible for bonuses, incentives or commissions.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Compensation Type:HoursMinimum Compensation:34.00Maximum Compensation:35.00