Operator/Packaging Specialist - (Pharma/GMP)
Clinigen · Malvern, PA · 1 wk ago
On-siteOTHRFull-time
About the role
Ensure the accurate packaging, labeling, and documentation of clinical trial materials in accordance with established protocols and regulatory requirements.
Responsibilities
- Follow step-by-step instructions to package and label clinical study medication
- Convert client documents to internal company documents
- Work with other team members to create consistent and uniform products
- Compare printed labels to the original proof to ensure they match character for character and with proper spacing
- Inspect products for defects and uniformity
- Work with supervisor and the quality department to investigate and correct documentation errors
- Learn and adhere to Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and CSM's Standard Operating Procedures (SOPs)
- Follow, promote, and enforce relevant SOPs, Job Aids, and Company policies and procedures
Requirements
- 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)
Skills
- Ability to work independently or within a team
- Detail-oriented to 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 a high regard for confidentiality while dealing with all clients, proprietary, and pharmaceutical-related information
- Highly computer literate; experience operating with all Microsoft Office software
Benefits
- Inclusive company culture that values diverse backgrounds and social styles
- Transparency with leadership through an employee engagement platform for anonymous feedback
- Competitive benefit offerings and programs that celebrate success