Quality Assurance Label Operations Specialist

2 days ago

New York, New York, United States Stark Pharma Solutions Inc Full time

Job Title:
Quality Assurance Label Operations Specialist

Location:
Summit NJ Onsite

Experience:
2+ years

Duration:
12+ Months

Schedule:
Wed Sat, 6:30 am 4:30 pm

Job Summary
Here's the thing. This role centers around keeping label control for a cell therapy manufacturing site running smoothly and accurately. You're the point person who makes sure every label printed, issued, and used in production meets GMP expectations and regulatory requirements. What this really means is you'll manage in-process and final product labels, maintain documentation, troubleshoot issues, support audits, and help strengthen the quality systems that keep patients safe.

Key Responsibilities

  • Support daily activities within the Label Control group.
  • Print and issue clinical and commercial in-process and final product labels.
  • Verify all printed data is correct and compliant with regulatory standards.
  • Coordinate closely with production to ensure labels are issued on time.
  • Train internal teams on label control and issuance requirements.
  • Write, revise, and maintain SOPs tied to label operations.
  • Assist with new product launches, new market preparations, and other quality initiatives.
  • Support internal and health authority inspections and audits.
  • Participate in deviation management, investigations, CAPA activities, and change control.
  • Handle supplemental investigations or projects assigned by management.
  • Keep up with current GMP and regulatory expectations.

Required Skills And Competencies

  • Strong working knowledge of GMP, Quality, and compliance.
  • Solid technical writing skills for reports and SOPs.
  • Ability to work independently with minimal supervision on routine work.
  • Skilled at managing time, prioritizing, and multitasking.
  • Comfortable making decisions on non-routine issues.
  • Accurate with data entry and reporting.
  • Strong communication skills and the ability to work across teams.
  • Experience with electronic document management and manufacturing execution systems.
  • Advanced computer proficiency.
  • Able to recognize issues and propose practical solutions.
  • Capable of supporting audits and inspections.

Education & Experience

  • Bachelor's degree required.
  • At least 2 years of relevant experience in pharma or a GMP-regulated environment.
  • Must have hands-on experience with deviations, CAPA, SOP writing, and project management.

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