Quality Control Inspector – Clinical Trial Materials (cGMP)

Clinigen Group; Malvern (AR); On-site; USD 55,000 - 75,000; Full time

Job summary

Clinigen Group in Malvern, AR, is seeking a quality-focused inspector to ensure compliance with cGMP standards. The role covers inspection of clinical trial labels, incoming materials, in-process materials, and finished products on-site five days a week.

You will collaborate with operations, prepare documentation, and uphold SOPs and GDP practices to support secure, timely delivery of medicines.

Qualifications

• Must have a high school diploma or GED.
• Associates degree or 2 years of equivalent work experience preferred.
• Ability to partner with operations/supervisors to identify and correct problems.
• Experience with cGMP, GDP, or SOPs preferred.

Responsibilities

• Perform routine cGMP inspections, disposition and maintenance of clinical trial labels, incoming clinical trial materials, in-process clinical trial materials, and finished products.
• Prepare documents for use in cGMP activities.
• Complete in-process inspections during production to ensure products meet quality standards and are compliant with established quality systems.
• Work with other departments to identify, investigate and resolve issues using problem-solving skills.
• Communicates operational and personal concerns and opportunities for improvement to the department leadership.
• Know, understand and comply with the company’s standard operating procedures and policies.
• To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures.

Skills

Problem-solving

Detail orientation

Confidentiality

Communication skills

Time management

Relationship building

Education

High School Diploma or GED

Associates Degree or 2 years of equivalent work experience

Tools

Microsoft Office

Job description

Clinigen Group in Malvern, AR, is seeking a quality-focused inspector to ensure compliance with cGMP standards. The role covers inspection of clinical trial labels, incoming materials, in-process materials, and finished products on-site five days a week.

You will collaborate with operations, prepare documentation, and uphold SOPs and GDP practices to support secure, timely delivery of medicines.