What are the responsibilities and job description for the Quality specialist position at Net2Source Inc.?
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries.
We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.
Job Title : Quality Records Specialist
Location : Summit, NJ 07901 - 100% onsite
Duration : 12 months contract
Work schedule : Mon- Fri (normal business hours)
Must Haves :
- initiating and managing deviations and change controls in quality systems
- 1 years in QA
- Create and revise SOPs
PURPOSE AND SCOPE OF POSITION :
The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL).
Other duties may include Coordinate testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a BMS CoA / CoT.
This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.
REQUIRED COMPETENCIES :
Knowledge, Skills, and Abilities :
- Experience with deviation and change control management, preferably with Infinity systems
- Strong organizational skills, including ability to follow assignments through to completion
- Ability to work in a fast-paced environment, meet deadlines, and prioritize work from multiple projects
- Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams
- Detail oriented with demonstrated application in problem solving
- With moderate oversight from manager, think strategically and understand global impact of decisions
DESIRED COMPETENCIES :
Knowledge, Skills, and Abilities :
- Advanced project management skills such as process excellence / six sigma methods and approaches including process mapping, root cause analysis and problem definition
- Experience within the Cellular Therapeutics and / or gene-based products. Experience with biologics will be considered.
Experience with Clinical and / or Commercial products manufacture, supply and post-approval change management
Knowledge of applicable FDA / EMA regulations in the biotechnology industry
Experience managing external suppliers and other supply chain issues
Education and Experience :
Preferred Bachelors in relevant scientific discipline, or 3 years’ experience in biotherapeutics / biomanufacturing QC / QA
DUTIES AND RESPONSIBILITIES :
- Initiation, facilitation, and tracking of quality records
- Provide regular communication and metrics for status of quality records
- Effectively communicate issues, risks and proposed solutions within the organization
- Provide communication, support, and guidance to CTLs within the QA vector and upstream material team
Other duties may include :
- Create and revise SOP
- Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)
- Enter data and retrieve information from SharePoint and Smartsheet testing trackers
WORKING CONDITIONS (US Only) :
- May be required to work in office environment.
- Sitting, standing and computer work is required.
- Ability to participate in conference calls.
Last updated : 2024-11-19
