Quality Control Associate - (Pharma/GMP)

Clinigen; 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

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.