Quality Systems Associate

About Quality 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 Quality Systems Specialist ensures compliance with the Quality System requirements, works collaboratively with all other departments, and provides support for continued development, improvement and implementation of the Quality Systems as well as maintaining compliance with regulations, standards, and company requirements.

This position is based in Malvern, PA, USA, will require on-site support 5 days/week.

To be successful in this role you should have:

• Bachelor of Science degree
• 2-3 years of experience in the biopharmaceutical industry
• Experience with GMPs, GXPs, EU directives, ICH guidelines
• Experience in creating and implementing a quality system

Your role at Clinigen:

• Create, review and maintain quality system SOPs, records and other documents to define and approve quality system functions as assigned
• Assist the Quality Systems Manager with client and regulatory audits and inspections, including audit responses and tracking
• Maintain the audit schedule and audit files
• Initiate and execute internal audits and supplier audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent corrective action status
• Ensure all CAPAs are entered into the quality system, assigned to the appropriate personnel, and completed according to CAPA procedures and within specified time periods
• Work with Subject Matter Experts to ensure CAPA content is accurate, well-documented, meets the requirement of the process, and is completed in a timely manner
• Work with other departments regarding documentation requirements and complex investigations
• Review Change Controls, schedules meetings, and tracks completion
• Assist the Quality Systems Manager with tracking and trending Quality System data
• Maintain current knowledge of quality assurance-related and regulatory-related government and industry standards as well as perform reviews and updates to ensure company policies and procedures are up to date
• Cross-training in high-priority areas is required to support team adaptability and address workflow strain

We’re excited about you if you have:

• Experience with various quality systems software
• Ability to read and interpret documents, such as SOPs and policies
• Ability to think critically and be innovative to incorporate process improvements
• Excellent communication skills and ability to communicate effectively with all levels of an organization

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.