QA Label Specialist Position Available In Union, New Jersey

QA Label Specialist 3.6 3.6 out of 5 stars Summit, NJ 07901

Job Title :

QA Label Specialist Location :

Summit, NJ Hours/Schedule :

Sun-Wed 4:00pm-2:00am

Compensation :

$27.00- $34.95

Type:

Contract Overview The Label Control Specialist is responsible for supporting site Label Control activities in accordance with policies, standards, procedures and Global cGMPs. Responsibilities include performing in process and drug product label printing activities, ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO). Responsibilities Supports all activities for the 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 B.S. Degree required Minimum 2 years relevant work experience Must have knowledge and experience with GMP, Quality, and compliance. Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills. Good understanding of electronic document management and manufacturing execution systems. Able to support internal and health authority inspections of facility 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