Sr. Drug Product Operations Sample 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 Drug Product Operations Sample Coordinator is accountable for driving results in a fast-paced environment by facilitating the log in of samples and projects for lab documentation, coordinating the sampling and the transfer materials/components and drug products from manufacturing to the laboratory, and managing the project timelines for issuance of COAs. The Sr. DP Operations Sample Coordinator provides administrative and organizational support related to materials management activities in manufacturing. The ideal candidate will maintain documentation and files to assure they are accurate, up-to-date, and available to appropriate personnel.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:30pm.

Responsibilities

• Receives incoming samples for laboratory testing and initiates chain-of-custody tracking in electronic system.
• Samples involve raw materials, bulk drug substances, components, formulation prototypes, in-process and finished drug products.
• Manages the labelling, storage, chain-of-custody, and disposition of samples (including controlled substances). 
• Uses computer software programs to generate projects for laboratory testing. Laboratory experience with analytical testing is preferred, as this experience provides a solid foundation for the technical aspects of project creation and management.
• Communicates and collaborates with the Manufacturing, Formulation, Project Management, Laboratory and Quality teams to ensure batch records, analytical methods and specifications are released.
• Coordinates and schedules the raw material and components sampling for testing, and maintains responsibility for the transport of samples from manufacturing to labs.
• Sets the committed dates and monitors the status of laboratory testing to ensure COA is issued on time.
• Conducts weekly meetings and communicates routinely with all key stakeholders.
• Handles the logistics for outsourcing work, from requesting quotes and PO to receiving results for reporting.
• Performs documentation accurately and completely.
• Complies with safety policies and procedures.
• Works efficiently in a team setting, with ability to multi-task in a high-pace environment.
• Ensures timely completion and compliance with cGMP, EHS, DEA, and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related field preferred and 2+ years of related experience required.
• High school diploma or GED and 6+ years of related experience required.
• Pharmaceutical, CDMO, or cGMP experience strongly preferred.

Knowledge, Skills, and Abilities

• Multi-tasking and attention to detail skills required.
• Working knowledge of computer-based networks and document management systems preferred.
• 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; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.