Quality Records Specialist - sunrise systems : Job Details

Sunrise Systems Inc is currently hiring an Quality Records Specialist in Summit, NJ with one of our top client.

Job Title: Quality Records Specialist

Job ID: 59670-1

Location: Summit, NJ

Duration: 12 Months contract on W2

Job Description:

Position Summary:

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

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

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.

Regards,

Ginulal| Sr. Recruiter

Office: (732) ### ####

Email: [email protected]