What are the responsibilities and job description for the Sample Management Coordinator -- EX39645859371 position at Compunnel Inc.?
Job Summary
The Sample Management Coordinator supports GMP manufacturing operations by managing production sampling activities, batch documentation, laboratory information systems, and cross-functional coordination. This role is responsible for ensuring accurate and timely sample processing, GMP-compliant documentation, data entry, and communication between Manufacturing, Quality Control, and other stakeholders to support product quality and successful batch release activities.
The ideal candidate is highly organized, detail-oriented, and experienced in regulated manufacturing environments, with strong administrative, documentation, and communication skills.
Key Responsibilities
Sample Management & Coordination
Perform production sampling activities in support of daily GMP manufacturing operations.
Aliquot production samples and deliver them to the Quality Control (QC) laboratory within established timelines.
Coordinate daily sampling schedules using sample tracking tools and communicate priorities with stakeholders.
Escalate sampling or scheduling issues as needed to ensure uninterrupted operations.
Coordinate sample shipments to Denmark and other locations as required, ensuring compliance with applicable procedures and timelines.
Batch Documentation & Data Management
Create production batches and generate labels within GLIMS to support manufacturing activities.
Print, review, and manage paper batch records for accuracy, completeness, and GMP compliance.
Enter GMP production data into GLIMS accurately and in a timely manner.
Support batch release activities through proper documentation and data management.
Maintain data integrity and ensure compliance with quality and regulatory standards.
Manufacturing & Quality Support
Collaborate with Manufacturing, Quality Control, and other cross-functional teams to support production and quality objectives.
Assist in resolving production, sampling, and documentation issues.
Ensure right-first-time execution of sampling and documentation activities.
Support continuous improvement initiatives related to manufacturing and quality operations.
Documentation Control
Perform minor document revisions and updates in accordance with document control procedures.
Maintain accurate records and documentation required for GMP-regulated environments.
Ensure all documentation complies with company policies, SOPs, and regulatory requirements.
Compliance & Safety
Follow all Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and company policies.
Adhere to environmental, health, and safety requirements at all times.
Safely wear and operate a Powered Air-Purifying Respirator (PAPR) during required sampling activities.
Maintain a safe and compliant work environment while supporting manufacturing operations.
Communication & Stakeholder Support
Maintain clear and professional communication with internal stakeholders.
Provide updates regarding sampling schedules, documentation status, and operational issues.
Support daily production operations through timely completion of assigned tasks.
Assist with additional duties and special projects as needed.
Required Qualifications
Associate's Degree in a related field from an accredited institution, or an equivalent combination of education and experience.
Minimum 1 year of pharmaceutical manufacturing experience is required.
Strong proficiency with Microsoft Office applications, including:
Word
Excel
PowerPoint
Outlook
Excellent organizational, planning, and time management skills.
High attention to detail and accuracy.
Strong verbal and written communication skills.
Ability to prioritize multiple tasks and meet deadlines in a fast-paced environment.
Ability to work effectively with cross-functional teams.
Understanding of documentation management and administrative processes.
Preferred Qualifications
2-3 years of administrative experience, preferably within a pharmaceutical or GMP-regulated environment.
Experience with:
LIMS/GLIMS systems
PAS-X
Batch documentation management
GMP manufacturing processes
Experience with process improvements and problem-solving initiatives.
Experience training team members or serving as a Qualified 4P Trainer.
Clean 1 Star certification or similar qualification.
Knowledge of production sampling, quality systems, and batch release processes.
Physical Requirements
Ability to move equipment and supplies weighing up to 33 pounds.
Ability to perform close precision work requiring manual dexterity.
Ability to remain in stationary positions (sitting and standing) for approximately 50% of the workday.
Ability to occasionally climb ladders and work at elevated heights.
Ability to work in environments where exposure to odorous or hazardous materials may occur.
Ability to wear required PPE, including a Powered Air-Purifying Respirator (PAPR).
Certifications (If Any)
No specific certifications required.
Experience or certification related to GMP, LIMS, PAS-X, 4P Training, or pharmaceutical manufacturing operations is considered a plus.
Clean 1 Star qualification preferred.