Quality Specialist II

Quality Specialist II

Improving Health through Science and Technology!  At Gateway Analytical, an Aptar Pharma company, we specialize in Drug Delivery offering Innovative Devices, Services and Solutions focused on Patient Experience.  Aptar Pharma is part of Aptar Group, a global leader of dispensing systems for the packaging industry.  Aptar Pharma has been setting the standard in drug delivery for decades providing health technology solutions and services enabling effective patient treatment.  Be You, Be Aptar! 

What You Will Do at Aptar Pharma:

We have an exciting new opportunity as Quality Specialist for Gateway Analytical to oversee the planning, coordination, and execution of both internal and external audits. This role involves responding to audit findings, ensuring compliance to quality standards, and leading efforts to enhance inspection readiness. Quality Specialist plays a pivotal role in developing and enhancing audit management processes and systems to ensure continuous regulatory compliance.

What Aptar Pharma Is Looking For:

The Quality Specialist is responsible for performing the following activities:

•     Planning and Hosting Client Audits:

• • Lead the preparation and planning of client audits.
  • Coordinate schedules, gather necessary documentation, and ensure efficient audit processes.
  • Manage client inquiries and facilitate communication between clients and internal teams during audits.
  • Respond to audit reports by leading internal reviews and driving the resolution of client audit findings through CAPA records.

•     Internal and External Audits:

• • Conduct and lead internal QA audits, identifying areas for improvement and ensuring compliance with quality standards.
  • Support vendor/supplier audits by coordinating data collection and report generation.
  • Conduct regulatory gap assessments, identifying and addressing potential compliance issues.

•     Inspection Readiness:

• • Collaborate with cross-functional teams to improve inspection readiness by maintaining accurate documentation and implementing QA best practices.
  • Lead ongoing projects aimed at improving audit processes and overall compliance readiness.

•    Project Review

• • Reviewing and approving raw data, reports, and other supporting documents.
  • Halting work when serious quality deficiencies are found or suspected
  • Performing final quality closure reviews

•     Training:

• • Assisting in new hire training and other Quality related training

•     Supporting Quality records (e.g., Deviations, CAPAs, Change Control, OOS) as needed.

• • All duties as assigned by management
    
    

What you will bring to the journey:

Education:

• Minimum Bachelor’s degree in a related field (or equivalent experience).

Experience:

• 3+ years’ experience in a regulated industry (e.g., pharmaceutical, ISO), quality assurance, audit coordination, or related fields. 
• Certification/Licensure/Qualification: Internal Auditor certificate in one or more ISO Standards would be preferred.
• Training: Lead Auditor training
  
  

Skills:

• Proficient in quality assurance (QA) processes and audit management.
• Gateway Analytical is regulated by the FDA and EMA and accredited to ISO 9001 and ISO 17025. Experience with applicable standards is preferred. 
• Strong communication and interpersonal skills for working with clients, team members, and stakeholders.
• A keen interest in a fast-paced scientific learning environment with an emphasis on applying new skills.
• Basic laboratory equipment knowledge, word processing skills, team-oriented and strong work ethic.
• Critical thinking and problem-solving skills. 

What We Offer