Materials & Lab Coordinator

• Coordinate with Lab Operations to ensure timely qualification and requalification of Reference Standards and Reference Materials in accordance with internal procedures and regulatory expectations.
• Manage the proper storage, handling, and inventory control of Reference Standards within designated secure areas to maintain integrity and traceability.
• Maintain complete and accurate records for all Reference Standards and Materials in SampleManager LIMS, including updates related to qualification status, usage, and disposition.
• Purchase Reference Standards from compendial sources, ensuring that storage and handling follow compendial instructions and internal standard operating procedures.
• Request Reference Standards and updated Certificates of Analysis from clients as needed to support testing activities and documentation requirements.
• Maintain up-to-date inventory lists and Certificates of Analysis for all Reference Standards and Materials, ensuring easy access for audits and inspections.
• Distribute Reference Standards and Reference Materials to laboratory staff, including Laboratory Scientists, in a timely and controlled manner.
• Monitor inventory levels of Reference Standards and Materials and promptly notify Project Leaders when stock is low or requires replenishment.
• Dispose of Reference Standards and Materials when requalification is discontinued, following approved procedures and documentation requirements.
• Participate in project kick-off meetings as required to understand material needs, timelines, and documentation expectations.
• Maintain a safe working environment by following safety procedures, using appropriate controls, and promptly reporting potential hazards.
• Perform rotating or alternating shift work as required to support continuous laboratory operations and ensure material availability.
• Support audit readiness by maintaining compliant records, documentation, and inventory controls aligned with GMP and laboratory standards.

• Minimum of 3 years of experience in a pharmaceutical or regulated laboratory environment.
• Demonstrated experience working in a GMP-controlled setting with strict documentation and compliance requirements.
• Hands-on experience with Reference Standards or Reference Materials, including qualification, handling, and documentation.
• Experience with sample tracking and inventory management in a regulated setting.
• Familiarity with Certificates of Analysis, including requesting, reviewing, and maintaining COAs for laboratory materials.
• Ability to use and maintain records within a Laboratory Information Management System (LIMS), preferably SampleManager LIMS.
• Strong attention to detail and organizational skills for managing inventories, records, and documentation.
• Ability to collaborate effectively with Laboratory Operations, Scientists, and other cross-functional stakeholders.
• Willingness and ability to work rotating or alternating shifts as required by laboratory operations.

• Experience supporting stability studies within a regulated laboratory environment.
• Experience in handling controlled substances under secure storage and documentation requirements.
• Familiarity with maintaining training records and supporting compliance-related documentation.
• Experience in laboratory purchasing, including working with specifications and compendial sources.
• Previous experience as a Laboratory Assistant or in similar laboratory support functions.
• Understanding of GMP, compliance requirements, and audit expectations in a pharmaceutical setting.

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent