QA Specialist - Batch Release Officer

Regulatory Toolkit

Raleigh (NC)

On-site

USD 70,000 - 95,000

Full time

7 days ago
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Benefits offered by this job

Health coverage
Retirement and pension plans
Life insurance
Disability coverage
Employee assistance programmes
Training and career development

Job summary

ICON Strategic Solutions is seeking a QA Specialist - Batch Release Officer to join our sponsor-dedicated team in Raleigh, NC. You’ll lead quality assurance activities for batch release, ensuring compliance with regulatory standards and industry requirements in pharmaceutical logistics.

Experience in quality management, audits, and documentation control is essential, and you will drive continuous improvement initiatives.

Qualifications

  • Degree in Quality Management, Logistics, Pharmacy, or related field.
  • Experience in quality control within logistics/pharma with regulatory knowledge.
  • Strong analytical, organizational, and communication skills.

Responsibilities

  • Implement and manage quality control procedures to ensure regulatory compliance.
  • Conduct audits and inspections of processes, facilities, and documentation.
  • Collaborate with cross-functional teams to improve QC strategies.
  • Provide guidance and training on QC procedures to staff.
  • Maintain records and reports, resolve quality-related concerns.

Skills

Quality assurance
Regulatory knowledge
Audits
Quality control

Education

Quality management degree
Logistics degree
Pharmacy degree

Job description

QA Specialist - Batch Release Officer

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior Logistics Quality Control Coordinator at ICON, you will ensure the highest standards of quality and compliance within our logistics operations.

What You Will Do:

You will lead on quality assurance and compliance tasks requiring technical depth, with a focus on quality and continuous improvement.

Key responsibilities include:

  • Implementing and managing quality control procedures to ensure compliance with regulatory requirements and industry standards for pharmaceutical logistics.
  • Conducting regular audits and inspections of logistics processes, facilities, and documentation to identify and address any quality issues.
  • Collaborating with cross-functional teams to develop and enhance quality control strategies and best practices within the logistics operations.
  • Providing guidance and training on quality control procedures to logistics staff and other relevant stakeholders.
  • Maintaining accurate records and reports related to quality control activities and ensuring timely resolution of any quality-related concerns.
Your Profile:

You will have a strong foundation in quality assurance and compliance, with the experience to work independently and guide others.

Required qualifications and experience:

  • Degree in Quality Management, Logistics, Pharmacy, or a related field.
  • Proven experience in quality control within the logistics or pharmaceutical industry, with a deep understanding of regulatory standards.
  • Strong analytical skills with the ability to conduct detailed audits and assessments of quality control processes.
  • Excellent organizational and communication skills, with the ability to work effectively with diverse teams and manage multiple priorities.
  • Demonstrated ability to identify issues and drive improvements in quality control practices and logistics operations.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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