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Quality Control Specialist II, Sample Management [Contract to Hire]

Iovance Biotherapeutics, Inc.

Philadelphia (Philadelphia County)

On-site

USD 50,000 - 80,000

Full time

12 days ago

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Job summary

A forward-thinking company is seeking a Quality Control Specialist II to manage the logistics of quality control samples. This role involves ensuring the integrity and timely distribution of samples in compliance with cGMP standards. The ideal candidate will possess strong organizational and communication skills, along with a Bachelor's degree or relevant experience in GMP and Sample Management. Join a dynamic team dedicated to excellence in the pharmaceutical industry, where your contributions will directly impact quality assurance and regulatory compliance in a fast-paced environment.

Qualifications

  • Bachelor’s degree or 2+ years of GMP and Sample Management experience required.
  • Detail-oriented with strong mathematical and communication skills.

Responsibilities

  • Manage QC sample logistics for raw materials and final products.
  • Maintain sample integrity and accurate inventory records.
  • Support audits and inspections while adhering to safety SOPs.

Skills

Detail-oriented
Mathematical skills
Communication skills
Collaboration skills
Time management
Organizational skills
Problem-solving
Adaptability

Education

Bachelor's degree
2+ years of GMP and Sample Management experience

Tools

LIMS

Job description

Quality Control Specialist II, Sample Management [Contract to Hire]

Join to apply for the Quality Control Specialist II, Sample Management [Contract to Hire] role at Iovance Biotherapeutics, Inc.

Overview

The Quality Control Specialist II, Sample Management will ensure the timely distribution of quality control samples supporting QC activities. Responsibilities include managing sample inventory, internal and external sample distribution, storage, and shipping under appropriate conditions for all iCTC cell therapy assets.

Shift
  • Sunday to Wednesday from 9am - 8pm
  • Wednesday to Saturday from 9am - 8pm
Essential Functions and Responsibilities
  • Manage QC sample logistics for raw materials, in-process, and final products, including storage, inventory reconciliation, scheduling, and shipping in LIMS.
  • Maintain sample integrity according to procedures, specifications, and cGMP standards.
  • Distribute samples internally and externally to testing vendors promptly.
  • Maintain accurate sample inventory records.
  • Stay updated on regulations, policies, industry best practices, and standards to ensure compliance.
  • Support audits and inspections.
  • Package samples using temperature-controlled dewars, cold packs, and dry ice.
  • Perform Quality Control activities and peer reviews of logbooks.
  • Adhere to company values, policies, procedures, and ethics.
  • Comply with safety SOPs, SDS sheets, and OSHA regulations.
  • Complete and document training sessions.
  • Follow GMP and SOP procedures including GDP.
  • Perform cycle counts and assist in documentation updates.
  • Act as a subject matter expert in specific areas and transfer knowledge to new employees.
Required Education, Skills, and Knowledge
  • Bachelor’s degree or 2+ years of GMP and Sample Management experience.
  • Detail-oriented with strong mathematical skills.
  • Excellent communication skills.
  • Strong collaboration, time management, and organizational skills.
  • Ability to work effectively with diverse stakeholders.
  • Good judgment, problem-solving, and adaptability in fast-paced environments.
  • Hands-on experience with sample handling, inventory, and cryo-shipping.
Preferred Education, Skills, and Knowledge
  • Experience with inventory and logistics in the pharmaceutical industry.
Physical and Environmental Demands

Must be able to stand or sit for prolonged periods, lift up to 10 pounds, and work in lab and cleanroom environments with chemicals, biohazards, and noise. Visual acuity and repetitive motion are required.

Mental and Work Environment

Requires strong judgment, troubleshooting, stress management, and the ability to handle multiple priorities. The work environment includes office and laboratory settings with chemical and biological exposures.

Additional Information

This description outlines general responsibilities and may be updated. Iovance promotes diversity and inclusivity. For accommodations, contact careers@iovance.com. By applying, you consent to data collection per our privacy policy.

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