Quality Control Associate - (Pharma/GMP)
Clinigen
Summary
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.
Job description
Your role at Clinigen
- 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 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 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
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
Requirements
- High School Diploma or GED required
- Associates Degree or 2 years equivalent work experience preferred
- 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)
- Detail oriented and self-motivator
- High regard for confidentiality
- Excellent oral and written communication skills and active listening ability
- Excellent time management skills
- Ability to develop effective working relationships
- Highly computer literate; experience with Microsoft Office software
Benefits
- Inclusive culture
- Employee engagement platform
- Competitive benefits
Company overview
Clinigen is a leading global pharmaceutical services company dedicated to accelerating access to medicines for patients worldwide. Founded in 2008 and headquartered in Burton upon Trent, United Kingdom, the company specializes in providing comprehensive solutions across the pharmaceutical supply chain, including clinical trial supplies, unlicensed medicines, and licensed medicines distribution. With operations spanning over 10 countries and approximately 1,100 employees, Clinigen focuses on delivering the right medicine to the right patient at the right time. The company's services encompass clinical trial packaging and labeling, global storage and distribution, comparator sourcing, and specialized access programs for rare diseases and difficult-to-treat conditions. Clinigen plays a crucial role in bridging gaps between pharmaceutical manufacturers, healthcare providers, and patients, particularly in areas where traditional distribution channels may be insufficient. Their patient-centric approach emphasizes improving healthcare outcomes by ensuring timely access to critical therapies, making them a key partner in the global pharmaceutical ecosystem.