QA Label Specialist
Company: Joulé
Location: Summit
Posted on: June 25, 2025
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Job Description:
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
Keywords: Joulé, Fairfield , QA Label Specialist, Science, Research & Development , Summit, Connecticut
