Document Control Specialist II
Hiring Company: BioPhase Solutions Inc.
Location: San Diego, CA
Job Type: Quality Assurance
Description: BioPhase Solutions specializes in recruiting talented professionals for San Diego’s Scientific and Clinical Research community. We currently have an opening for a Sr. Document Control Associate with experience in the Biopharmaceutical industry.
SAN DIEGO CANDIDATES ONLY PLEASE!!!
• Organize and ensure accurate and reliable filing systems for all paper-based GMP documents.
• Ensures all training is complete by all GXP personnel and up to date in the EDMS system.
• SME in managing and transferring paper based system to EDMS system document solutions for the organization (Master Control).
• Provides timely documentation for the organization and contract customers.
• Responsible for CGMP for maintenance of accurate and complete QMS records, standard operating procedures and other controlled documentation.
• Must clearly and frequently articulate and influence the “quality position” at the site.
• Input data for tracking quality metrics as required.
• Provide Communication on the document control system with direct manager, on a routine basis.
• Trains end users on EDMS/LMS Document Control Management application as needed.
• Responsible for assisting in PAI and other inspection readiness.
• Supports the development and management of quality metrics to optimize performance, productivity and effective resource planning.
• Responsible for off-site document archival and destruction per company policies.
• Participates in cross-functional project teams.
• Assist in Due Diligence activities.
• Bachelor’s degree in a life science preferred with a minimum 5+ years of experience in a GXP document control position, and 5+ years of experience in archiving, inventory, maintaining and creating paper based systems and EDMS.
• Strong experience with Document Management in Master Control. Implementation and deployment of Master Control systems is highly desirable.
• Strong Document Control experience in support of FDA submissions/inspections. New Drug Application (NDA) is highly desirable.
• Excellent communication skills, with strong organizational, planning and follow-through, and computer skills. Ability to prioritize and multi-task independently.
• Ability to think analytically and attention to detail, exercise judgment within generally defined practices and policies in selecting methods and techniques to resolve complex problems positively and professionally.
• Demonstrated leadership skills and ability to interact with all levels of management in a multi-disciplinary team environment.
• Knowledge and understanding of ICH, CGMPS for Pharmaceuticals and Devices and relevant regulatory requirements.
• Quality-service attitude and willingness to work additional hours to meet deadlines.
Email address to send resume: firstname.lastname@example.org