Job Title: QA Label Specialist 
Location: Summit, NJ
Hours/Schedule: Wednesday - Saturday; 2nd Shift (4p - 2am)
Type: Contract
 
Overview
The Quality Assurance Label Control (QALC) Labeling Specialist supports the cGMP Label Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records. 

Responsibilities Supports all activities for the Quality Assurance Label Control group. Responsible for issuing clinical and commercial in-process and final product labels for labeling operations. Responsible for ensuring accurate printed information on labels in compliance with health authority requirements. Coordinates with production teams to ensure timely issuance of labels. Performs training of label control and issuance requirements for internal personnel as needed. Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required. Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned. Provides support during internal and health authority inspections and audits of facility. Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management. Performs supplemental investigations/projects as required by Management. Maintains knowledge of current GMPs and regulatory guidelines. Requirements Bachelors degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment. Some document management experience. Crystal reports experience preferred . Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System). Possess project management skills. Experience interacting with FDA or other regulatory agencies strongly preferred. Strong knowledge of cGMPs and domestic regulatory requirements. Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.). 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. 


Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.