About the Company: A global pharmaceutical company
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
Your Main Responsibilities:
Recognized as a technical resource within their discipline; answering questions and requests related to the DMS (CMC, QA, System Downtime, etc) and incidents and service requests
DMS Business Owner responsibilities
Maintain GXP archives, including receipt, processing and storage of GXP records.
Facilitate the lifecycle of controlled documents in the electronic document management system (document creation, revision, issuance, and obsolescence)
QA Controlled Documents (Standard Operating Procedures, Work Instructions, etc.)
Document Distribution (including batch record and logbook issuance)
Interacts with internal and external customers and functional groups at various management levels to provide excellent customer service
Basic Qualifications:
S. in a scientific or allied health field (or equivalent degree) and 3 - 5 years of relevant work experience, or
Relevant comparable background
Experience working in Electronic Document Management Systems (Doc Compliance, Veeva, Documentum, etc)
Presents a solid understanding of quality assurance concepts and practices
Demonstrates knowledge of applicable regulations and the interpretation and application of regulations and compliance concepts related to document control
Responsible for all GxP Archiving Activities and regulatory knowledge
Presents a solid understanding of both digital and paper document control best practices
Exercises independent judgment to optimize compliance procedures and identify opportunities for continuous improvement
Able to manage and anticipate client expectations
Displays effective communication skills (written and verbal), within their area(s) of expertise Responsible for reviewing and authoring SOPs and Work Instructions, with minimal supervision
Acts as a representative of their Quality division on assigned project sub-teams and/or task forces
Demonstrates proficiency in influencing others within project teams regarding quality or compliance concerns
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
