Quality - Quality Records Specialist

Job Description : % onsite required

Work schedule : Mon- Fri(normal business hours)

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 Client 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

Experience with Quality Systems (change control, deviation and investigation)

Education and Experience :

Preferred Bachelors in relevant scientific discipline, or 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.

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.

Additional Job Requirements :

None

EEO :