Operator/Packaging Specialist - (Pharma/GMP)

Clinigen; Malvern (Chester County); On-site; USD 38,000 - 62,000; Full time

Job summary

Clinigen in Malvern, PA is seeking a detail-oriented packaging specialist to label and document clinical study materials per GDP and cGMP standards.

You will convert client documents into internal records, compare labels to proofs for exact matches, and work with QA to resolve documentation issues while maintaining strict confidentiality.

This full-time position requires 6–12 months of relevant experience and familiarity with SOPs, GDP, and cGMP; proficiency with Microsoft Office is expected.

Qualifications

• 6–12 months experience in an office setting or medical field.
• Preferred: 1 year SOPs, cGMP, GDP experience.

Responsibilities

• Package and label clinical study medication per SOPs.
• Convert client documents to internal documents.
• Collaborate with team to ensure consistent products.
• Compare printed labels to proofs for exact match.
• Inspect products for defects and uniformity.
• Assist QA and supervisor to correct documentation errors.
• Adhere to GDP, cGMP, and SOPs.
• Follow and enforce SOPs and company policies.

Skills

Detail oriented

Independent worker

Excellent communication

Time management

Team collaboration

Tools

Microsoft Office

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.

The primary objective of this position is to ensure the accurate packaging, labeling, and documentation of clinical trial materials in accordance with established protocols and regulatory requirements.

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.