Quality Records Specialist - Hybrid

QUALITY RECORDS SPECIALIST HYBRID SUMMIT, NJ Hybrid. Project Description:

• 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 shipping and testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a 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.
• 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:
  • Working closely with other GSQ QC members to submit and track sample material for testing at CTL.
  • 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.

• Associates of Science degree in relevant scientific discipline, or 3 years' experience in biotherapeutics/biomanufacturing QC/QA, or an equivalent combination of education and experience.
• 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.
• 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.
• Experience with Quality Systems (change control, deviation, and investigation).
• 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.
  • This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
  • There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
  • Employees holding this position will be required to perform any other job-related duties as requested by management.