Quality Operations Specialist

About Quality Operations at Clinigen:

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

The purpose of this position is to ensure compliance with established quality systems through the inspection of incoming clinical supplies, Clinical Trial labels and in-process materials.

To be successful in this role you should have:

• High School diploma or GED required
• Associate’s degree or 2 years equivalent work experience preferred
• Working knowledge of cGMP and Code of Federal Regulations (CFR) preferred

Your role at Clinigen:

• Perform routine cGMP inspections, disposition and maintenance of clinical trial materials
• Prepare documents for use in cGMP activities
• Complete in-process inspections during production to ensure products produced meet quality standards and are compliant with established quality systems
• Communicates operational and personal concerns and opportunities for improvement to the department leadership

We’re excited about you if you have:

• Ability to partner with operations/supervisors to identify and correct problems
• Detail oriented and a self-motivator
• Excellent oral and written communication skills
• Active listening ability
• Ability to develop effective working relationships with all associates at all levels

Benefits

While at Clinigen, you’ll enjoy:

The culture. Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.

The transparency with leadership. All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We’ve been able to take steps to continuously improve how we do things at Clinigen.

The benefits. We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.

EEO. Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.