Scalence L.L.C. · 1 week ago
Quality - Contract Documentation Specialist III
Branchburg, NJ
Full-time, Contract
Onsite
Mid Level
$45/hr - $47/hr
3+ years expScalence L.L.C. is a company seeking a Quality - Contract Documentation Specialist III. The role involves reviewing and managing documentation changes, ensuring compliance with regulatory requirements, and maintaining the Document Control System.
Information Technology & Services
Responsibilities
Implement, control and coordinate changes in documentation. Facilitates the updating and routing of controlled documents, including, but not limited to, Governance and Procedure documents, Master Forms and Master Batch Records within the eDMS
Manage the change process for manufacturing documentation consisting of SOPs, policies, manufacturing documentation, specifications and other controlled documents
Review, edit and process changes to controlled documentation such as procedures, manufacturing records, forms etc. in an electronic document management system
Ensure proper approvals have been obtained prior to final release of document and coordinate effective dates with departments
Preparation of records for issuance to production
Coordination and maintenance of the periodic review system
With minimal supervision, complete special projects and routine work on schedule
Qualification
Required
Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area
3+ years' experience in quality assurance, quality oversight or relevant experience
Experience in regulated pharmaceutical/medical device industry and document management areas
Proficient in Client Word and Excel
Excellent proofreading skills
Excellent verbal and written communication skills
Good analytical, decision-making and problem-solving skills
Experience working in both team setting and independently
Works well with manager guidance to complete tactical objectives while able to manage own time effectively
Excellent interpersonal skills
Ability to identify, communicate and follow through to completion action plans to resolve problems
Preferred
Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area
Experience in regulated pharmaceutical/medical device industry and document management areas
eDMS experience (Veeva Vault)
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase