Job Title: Quality Records Specialist

Location: Summit, NJ

Hours/Schedule: Mon- Fri Business hours

Type: Contract

Overview

Leading pharmaceutical company looking for an experienced Quality Records Specialist. Ideal candidates should have experience with deviation and change control management, preferably with Infinity systems.

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

  Requirements

• 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)

• Preferred Bachelors in relevant scientific discipline, or 3 years’ experience in biotherapeutics/biomanufacturing QA

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.