Roche→
Document Control Specialist at Roche in Philadelphia, PA
Skills
Job Description
Elevate your career at our dual-suite facility, where we bridge the gap between global commercial excellence and pioneering clinical research. The individual will collaborate with the document control team in providing administrative support in processing different types of documents in the EDMS along with managing multiple projects within document control department and help support/ maintain changes to the document management system.
The Opportunity:
Manage and maintain controlled documents in Electronic Document Management System (EDMS) ensuring documents go through controlled documents life cycle in accordance established procedures.
Independently review SOPs, form content and exercise judgment to provide suggestions to document authors to ensure alignment with controlled document procedures and best practices.
Track controlled documents to ensure reviews and approval are completed within the EDMS.
Manage file rooms inventory, filing, scanning and offsite documents archival with identified vendors.
Provide site training on EDMS workflow to other departments before granting user access.
Coordinate the review, finalization, and archival of policies, procedures, and other controlled documents.
Train and provide oversight to document control contractor(s) staff in processing documents in the EDMS, issuance logbooks, notebooks, and batch records.
Manage EasyVista (EV) on all incidents and requests for the EDMS and close all tickets in a timely manner.
Serve as an administrator of the EDMS including user account management, system configuration, troubleshooting and work with EDMS vendor(s).
Provide documentation support during audits and regulatory inspections.
Edit and proofread controlled documents for consistency of document format and template requirements, and adherence to quality systems processes and procedures.
Implement and utilize advanced Word processing and automation features of MS Office software.
Who You Are:
BS / BA in Biology, Chemistry, Engineering, related science discipline or equivalent experience is required
2-5 years of experience in working with documentation in a regulated industry
Computer literacy required; advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)
Knowledge of GMP concepts and guidelines
Experience with document control activities and systems
Requires strong written, oral, interpersonal, and communication skills and English fluency
Effective knowledge of maintaining a document and data control system
Effective organization and planning skills
Demonstrated ability to adapt to frequent changes, delays, or unexpected events
Ability to follow established policies, procedures and comply with regulatory requirements related to documentation
Demonstrated ability to perform detail-oriented work with a high degree of accuracy and completeness
Must have general understanding of FDA regulatory requirements as they relate to documentation.
Extensive MS Word processing and formatting experience
Experience in automating process utilizing MS Office products
Must have a strong attention to detail.
Ability to effectively communicate and share knowledge with a team.
This position may require occasional shift work, including weekends, off hours and holidays as needed
Relocation benefits are not available for this position.
The expected salary range for this position based on the primary location of Philadelphia, Pennsylvania is $62,400 to $115,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.