Quality Operations Associate - (Pharma/GMP)

Clinigen Group; Malvern (Chester County); On-site; USD 52,000 - 68,000; Full time

Job summary

Clinigen is seeking a QA inspector to ensure compliance with quality systems through inspection of incoming clinical supplies, trial labels, and in-process materials. This on-site role requires collaboration with operations and other departments to identify and resolve issues and to follow SOPs and GDP/cGMP practices.

The candidate will perform routine inspections, prepare necessary documents, and maintain compliance with established quality procedures to support reliable clinical supply chains.

Qualifications

• Partner with operations to identify and correct problems.
• Detail oriented and self-motivated with initiative.
• Excellent time management and ability to meet deadlines.

Responsibilities

• Perform routine cGMP inspections and disposition of clinical trial labels and materials.
• Prepare documents for use in cGMP activities.
• Complete in-process inspections to ensure product quality and compliance.
• Work with other departments to identify, investigate and resolve issues.
• Communicate operational concerns and opportunities for improvement to leadership.
• Know, understand and comply with SOPs and company policies.

Skills

High School Diploma or GED

Associate's Degree or 2 years' equiv. 

Education

High School Diploma or GED

Associate's Degree or 2 years' equivalent work experience

Job description

About 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.

This position requires on-site presence 5 days/week.

To be successful in this role you should have:

• High School Diploma or GED required
• Associates Degreeor2 yearsequivalent work experiencepreferred
• Ability to partner with operations/supervisors to identify and correct problems
• Preferred experience with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), or Good Documentation Practices (GDP)

Your role at Clinigen:

• Performroutine cGMP inspections, disposition and maintenance of clinical trial labels, incoming clinical trial materials, in-process clinical trial materials, and finished products
• Preparedocuments for use in cGMP activities
• Completein-process inspections during production to ensure products produced 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 personalconcernsand opportunities for improvement to thedepartmentleadership
• Know,understandandcomplywiththecompany’sstandardoperatingprocedures and policies
• To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures

We’re excited about you if you have:

• Ability to partner with operations/supervisors to identify and correct problems
• Detail oriented and self-motivator who takes the initiative to work independently and with the team
• High regard for confidentiality in dealing with all clients, proprietary and pharmaceutical related information
• Excellent oral and written communication skills and active listening ability
• Excellent time management skills to prioritize work and meet deadlines
• Ability to develop effective working relationships with associates at all levels to influence others and foster a cooperative work environment across the organization
• Highly computer literate; experience operating with all Microsoft Office software

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.