3rd-Party GMP Quality Operations Associate

cosettepharma; Lincolnton (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. in the United States seeks a Quality Assurance Associate to support 3rd party quality operations, maintaining quality documentation and overseeing customer complaints. The role involves reviewing GMP documents, assisting with investigations, and ensuring compliance with regulatory requirements.

Compensation will align with education and experience. Associate level placement will be determined based on education, industry experience, and demonstrated competencies,

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.

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.
• Perform other duties as assigned.

Skills

Organizational skills

Communication

Document review

cGMP knowledge

Attention to detail

Problem solving

Time management

Education

Bachelor's degree in science

Associate degree with experience

Tools

Microsoft Office

Veeva

Job description

Cosette Pharmaceuticals, Inc. in the United States seeks a Quality Assurance Associate to support 3rd party quality operations, maintaining quality documentation and overseeing customer complaints. The role involves reviewing GMP documents, assisting with investigations, and ensuring compliance with regulatory requirements.

Compensation will align with education and experience. Associate level placement will be determined based on education, industry experience, and demonstrated competencies,