Website LanceSoft, Inc.
This Jobsfunter Listing is about LanceSoft Inc in El Segundo, CA 2022
About the job
QA Document Specialist I
In this role, you will implement quality systems associated with Document Management with a focus on document processing and record management. You will also work closely with SMEs to execute workflows and business processes that align with best practices that ensure right first time.
The standard work week for this position is 5 days a week / 8 hour shifts with occasional additional workdays possible.
• Coordinate offsite document archival with approved vendors Perform GMP document and label issuance/ Perform documentation coordinator activities in eDMS and work with departments on documentation needs
• Responsible for the management of all documentation and records processing and archival processes to support clinical and commercial manufacturing
• Ensure GMP documentation tracking, reconciliation and archiving
• Support file room inventory, filing, and scanning Support document workflows electronic document management system ensuring documents go through controlled document life cycle in accordance established procedures.
• Ensure documents meet formatting and template requirements, adhere to required review and approval requirements and project timelines
• Ensure accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems
• Collaborate with cross-functional departments to ensure timely implementation of document change requests
• Execute strategic initiatives to improve the document management system
• Support training to new staff on document management processes and procedures
• Support audits (internal, external) in order to verify that regulatory and quality requirements have been met
• Bachelor’s Degree and 1+ years of experience in quality document management, quality engineering, validation, and quality assurance or quality systems OR
• AA Degree and 2+ years of experience in quality document management, quality engineering, validation, and quality assurance or quality systems OR
• High School Degree and 4+ years of experience in quality document management, quality engineering, validation, and quality assurance or quality systems
• Strong knowledge of GMP, SOPs and quality system processes
• Excellent organizational skills and ability to review processes or procedures
• Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, Documentum, Veeva or equivalent)
• Strong written and verbal communication skills
• Ability to communicate and work independently with scientific/technical personnel
• Experience in pharmaceutical or bio-pharmaceutical field
• Education or training in cell culture and gene therapy manufacturing environment
• Quality systems demonstrated working knowledge in areas such as document management, document change control audits, batch record and label issuance
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
Desired Skills and Experience
Company: LanceSoft, Inc.
Vacancy Type: Contract · Entry level
Job Location: El Segundo, CA
Application Deadline: N/A