Sample Management Coordinator

Primary Function

A leading pharmaceutical manufacturing organization is seeking a Sample Management Coordinator to support GMP manufacturing operations through production sampling, batch documentation management, and GLIMS-related activities. This role partners with manufacturing, quality, and cross-functional teams to ensure accurate, compliant, and timely execution of production processes that support product quality and batch release. The ideal candidate is detail-oriented, highly organized, and experienced in regulated manufacturing environments.

Duties & Responsibilities

• Create production batches and print labels within GLIMS to support daily manufacturing operations.
• Print, review, and maintain batch records to ensure accuracy, completeness, and GMP compliance.
• Enter GMP production data into GLIMS accurately and within established timelines.
• Aliquot production samples and deliver samples to the Quality Control laboratory to support batch release activities.
• Cooky daily sampling schedules and communicate updates to stakeholders using tracking tools.
• Escalate sampling or production issues as appropriate to maintain operational continuity.
• Cooky sample shipments as needed while ensuring compliance with applicable procedures and timelines.
• Cooky with cross-functional teams to support production, quality, and business objectives.
• Perform minor document revisions and updates in accordance with document control procedures.
• Follow all Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), safety requirements, and environmental policies.
• Wear and safely operate a Powered Air-Purifying Respirator (PAPR) when required.
• Maintain professional communication with internal stakeholders and support timely issue resolution.
• Complete assigned tasks accurately, efficiently, and within established timelines.
• Perform additional duties as assigned to support manufacturing and quality operations.

Skills & Qualifications

• Strong proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.
• Working knowledge of GMP requirements and pharmaceutical manufacturing practices.
• Experience using Laboratory Information Management Systems (LIMS) preferred.
• Knowledge of PAS-X or similar manufacturing execution systems preferred.
• Strong organizational, planning, and time-management skills.
• Excellent attention to detail and commitment to quality.
• Effective verbal and written communication skills.
• Ability to collaborate successfully with cross-functional teams.
• Demonstrated problem-solving and process improvement capabilities.
• Training experience or ability to support team development preferred.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

Education & Experience

• Associate’s degree in a related field from an accredited institution, or an equivalent combination of education and experience.
• 2-3 years of administrative experience, preferably within a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Minimum of one year of manufacturing experience in a pharmaceutical or similarly regulated environment preferred.

Physical Requirements

• Ability to move equipment and supplies weighing up to 33 pounds.
• Ability to perform close precision work with hands and fingers.
• Must be able to sit and stand for extended periods throughout the workday.
• Occasionally climb ladders and work at elevated heights.
• May occasionally work around odorous and/or hazardous materials.