Innova Solutions is immediately hiring a Quality Records Specialist

Job Title : Quality Records Specialist

Position type : Full-time Contract

Duration : 12 Months

Location : Summit, NJ 100% Onsite

As a Quality Records Specialist, you will :

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.

Required Competencies :

• 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 :

• Advanced project management skills such as process excellence / six sigma methods and approaches including process mapping, root cause analysis and problem definition
• Experience within 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 :

Bachelor's degree required in relevant scientific discipline, prefer 3 years’ experience in biotherapeutics or biomanufacturing QC / QA, or an equivalent combination of education and experience.

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 :
• 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

Thank you!

Sara Almas

Team Recruitment

PAY RANGE AND BENEFITS :

Pay range : $ 28 $ 29.96 Per Hour.

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Last updated : 2024-05-16