Jobs · OTHR · Pennsylvania

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

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