Sr. Materials Management Coordinator

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

 

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Job Summary

The Senior Materials Management Coordinator is accountable for driving results in a fast-paced environment by primarily coordinating samples throughout the manufacturing process. The Coordinator will log-in all samples that directly support the production process to ensure material availability for the production schedule and/or batch testing. This includes raw materials, components, in-process, bulk and/or finished product samples. This position also requires always maintaining sample integrity and ensuring correct documentation accompanies the log-in and shipment of samples when required. The ideal candidate will maintain documentation and files to assure they are accurate and up-to-date and available to appropriate personnel.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Uses multiple computer software programs to log in, manage, and maintain material status and testing requirements.
• Receives incoming samples for analysis and logs them into system to initiate chain-of-custody tracking.
• Manages laboratory sample storage, chain-of-custody, and disposition.
• Generates projects for laboratory testing
• Management of testing due dates between Analytical, Quality Control, Supply Chain and Project Management
• Conducts the controlled substances inventory and develops the destruction schedule, if applicable.
• Conducts controlled substance audits, if applicable.
• Performs documentation accurately and completely.
• Complies with safety policies and procedures.
• Communicates and collaborates routinely with other departments and clients.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Maintains sample and shipment documentation in appropriate files.
• Places purchase requisitions for sub-contracted testing as needed.
• Initiates Raw Material Sampling plans.
• Submits specification creation and/or revision requests as required.
• Coordinates shipment of samples to other testing locations and ensure samples are sent via specific storage conditions or per any other special instructions.
• Provides back-up support for supply chain functions including shipping, receiving, and material handling.
• Performs peer review.
• Trains others in techniques and procedures.
• Dependent upon site, this position may be required to supervise, handle, or process hazardous waste under Resource and Conservation guidelines promulgated under 40 CFR 262.177(a)(7), Personnel Training. This includes completion of initial and annual RCRA training and documented as required in Alcami records. This training also includes familiarity with emergency response procedures, emergency equipment, and emergency systems.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry or equivalent preferred.
• High school diploma or GED and a minimum of 4 years of related experience required.
• Prior cGMP experience required.
• Laboratory experience and/or experience with compendial testing is preferred, as this experience provides a solid foundation for the technical aspects of project creation and management.

Knowledge, Skills, and Abilities

• Ability to multi-task with high attention to detail skills required.
• Working knowledge of computer-based networks and document management systems preferred.
• Strong understanding of pharmaceutical manufacturing and testing preferred.
• Working knowledge of cGMP in a pharmaceutical or regulated environment preferred.
• Excellent verbal communications and presentation skills required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

Travel Expectations

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; w