GMP Quality Operations Associate – 3rd-Party

Jobtailor; Lincolnton (NC); On-site; USD 60,000 - 95,000; Full time

Job summary

Jobtailor is seeking a QA professional to administer complaints and support documentation across GMP systems in a regulated environment. The role involves reviewing batch records, investigations, and third-party GMP documentation, with emphasis on accuracy and adherence to regulatory requirements.

The ideal candidate brings experience in pharmaceutical/regulatory settings, strong organizational and communication skills, and proficiency with QA tools such as Veeva and Microsoft Office.

Qualifications

• Bachelor's degree in a scientific discipline preferred.
• Associate degree may be considered with relevant industry experience.
• Experience in pharmaceutical, biotechnology, medical device, or other regulated industry preferred.
• Experience with GMP documentation, quality systems, and regulatory requirements is preferred.
• Strong organizational, communication, and technical document review skills.
• Proficiency with Microsoft Office applications and QA tools.

Responsibilities

• Administer customer complaints within the applicable quality systems.
• Assist with review of batch records, investigations, specifications, complaint reports, and other GMP documentation from third-party manufacturers.
• Maintain supplier and contract manufacturer quality documentation files.
• Coordinate documentation requests with third-party manufacturers and internal stakeholders.
• Maintain accurate records in accordance with company procedures and regulatory requirements.
• Support continuous improvement initiatives and quality system compliance activities.

Skills

GMP Documentation

Quality Systems

Regulatory Requirements

Technical Document Review

Quality System Processes

Problem-Solving

Critical Thinking

Pharmaceutical Manufacturing

Continuous Improvement

Attention to Detail

Education

Bachelor's degree in a scientific discipline

Associate degree with relevant industry experience

Tools

Microsoft Office

Electronic Quality Management Systems

Veeva

Job description

Jobtailor is seeking a QA professional to administer complaints and support documentation across GMP systems in a regulated environment. The role involves reviewing batch records, investigations, and third-party GMP documentation, with emphasis on accuracy and adherence to regulatory requirements.

The ideal candidate brings experience in pharmaceutical/regulatory settings, strong organizational and communication skills, and proficiency with QA tools such as Veeva and Microsoft Office.