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CTO QA Label Specialist - 3rd Shift

Summit, NJ 07901

Posted: 09/07/2023 Job Number: 24929143

Job Description

100% onsite.
Schedule: Wed-Sat 8: 00 pm-6: 00 am (3rd shift).
The pay ranges between $46.42 - $48.14 per hour.

Project Description:
  • The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records.
  • To succeed in this role, you will have a strong attention to detail and an analytical mindset.
  • 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.

Required Skills:
  • Required Bachelor's degree or equivalent degree.
  • Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
  • Some document management experience.
  • Strong communication and customer service skills.
  • 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).
  • Develop and improve label issuance processes to drive operational efficiency.
  • Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
  • Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
  • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
  • Possess project management skills.
  • Strong knowledge of cGMPs and domestic regulatory requirements.
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
  • Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network.
  • Crystal reports experience preferred.
  • Experience interacting with FDA or other regulatory agencies strongly preferred.

Working Conditions (US only):
  • Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts.
  • Weekend and off-shift support may be required.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Malika: malika@alphaconsulting.Com


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Malika Peguero

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