Planet Pharma · 4 hours ago
QA Document Control Specialist
Philadelphia, PA
Contract
Onsite
Entry, Mid Level
$35/hr - $42/hr
2+ years expPlanet Pharma is seeking a QA Document Control Specialist to manage and maintain controlled documents in their Electronic Document Management System (EDMS). The role involves reviewing SOPs, tracking document approvals, providing training, and ensuring compliance with regulatory standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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 Spark 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 Spark 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
Qualification
Required
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
biotech, pharma or medical device experience REQUIRED
Computer literacy required; advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)
Knowledge of GMP concepts and guidelines
Experience with document control activities
Experience with document control 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 must be able to think critically and solve documentation problems
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase