Operator/Packaging Specialist - (Pharma/GMP)

Clinigen; Malvern (Chester County); On-site; USD 36,000 - 48,000; Full time

Job summary

Clinigen is seeking a detail-oriented professional to join our regulatory support team. You will follow step-by-step instructions to package and label clinical study medication, convert client documents to internal formats, and work with colleagues to ensure consistent, high-quality outputs while verifying labels against proofs.

Requirements: 6–12 months in an office or medical setting; preferred familiarity with SOPs, GDP or cGMP; strong communication, confidentiality, time management, and

Qualifications

• 6-12 months experience working within an office setting or medical field
• Preferred - 1 year of experience with SOPs, cGMP, or GDP

Responsibilities

• Follow step by step instructions to package and label clinical study medication
• Convert client documents to internal company documents
• Works with other team members to create consistent and uniform products
• Compares printed labels to the original proof to ensure they match character for character and with proper spacing
• Inspects products for defects and uniformity
• Works with supervisor and the quality department to investigate and correct documentation errors
• Learns and adheres to GDP, current cGMP, and SOPs
• To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures

Skills

Independence

Attention to detail

Communication skills

Time management

Discretion/Confidentiality

Teamwork

Tools

Microsoft Office Suite

Job description

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.

Your role at Clinigen

• Follow step by step instructions to package and label clinical study medication
• Convert client documents to internal company documents
• Works with other team members to create consistent and uniform products
• Compares printed labels to the original proof to ensure they match character for character and with proper spacing
• Inspects products for defects and uniformity
• Works with supervisor and the quality department to investigate and correct documentation errors
• Learns and adheres to Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and CSM's Standard Operating Procedures (SOPs)
• To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures

Requirements

To be successful in this role you should have:

• 6-12 months experience working within an office setting or medical field
• Preferred - 1 year of experience with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), or Good Documentation Practices (GDP)

We're excited about you if you have:

• Ability towork independently or within ateam
• Detail orientedto produce timely and accurate work
• Excellent oral, written,and interpersonal communication skills with active listening ability
• Self-motivated with exceptional time management skills to prioritize work and efficiently react to change in a fast paced environment
• Maintain ahigh regard for confidentialitywhiledealing with all clients, proprietary,and pharmaceutical related information
• Highly computer literate; experience operating with all Microsoft Office software

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.