Quality Assurance Label Specialist

1 day ago


Summit, New Jersey, United States Integrated Resources, Inc ( IRI ) Full time

Pay Range: $32 - $34.96/hr

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:


• 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.


• Requires moderate direction to complete more complex tasks; completes routing tasks with

little or no supervision.


• Must be time organized and possess an independent mindset.


• Good understanding of electronic document management and manufacturing execution

systems.


• Has advanced computer skills to increase department's productivity, as well as broadening

technical and scientific knowledge.


• Confident in making decisions for non-routine issues.


• Routinely recognizes and addresses quality opportunities to improve overall process/project

efficiencies.


• Proposes solutions for complex issues and works with management to resolve. Follows

established procedures and performs work as assigned.


• Builds relationships and effectively communicates internally within the function and with

internal and external cross-functional teams. Interacts with internal and external cross functional teams. Represents department in internal and external cross-functional teams.


• Contributes to goals within the work group.


• Able to recognize conflict and notify management with proposed recommendations for

resolution.


• Able to prepare written communications and communicate problems to management with

clarity and accuracy.


• Able to produce data reports with precision.


• Able to multi-task.


• Able to support internal and health authority inspections of facility

Education and Experience:

B.S. Degree required, minimum 2 years relevant work experience

DUTIES AND 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.



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