ANALYTICAL SERVICES COORDINATOR-1088140731
Description
Noramco, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Analytical Services Coordinator, located in Athens, GA.
Noramco, Inc. produces a variety of active pharmaceutical ingredients and is a major worldwide producer of medicinal analgesics, pharmaceutical intermediates and synthetic fine organic chemicals. It also produces monomers and polymers for pharmaceutical and medical devices.
This position’s key function is to coordinate and/or perform a variety of duties for the qualification and distribution of pharmaceutical substances, primarily reference standards and customer samples for the Scientific Affairs department. Specific responsibilities include: inventory management and packaging, order review, shipping (domestic and international), chemical and physical laboratory tests, and data review for Noramco analytical reference standard products and Scientific Affairs customer samples. Incumbent will partner with Customer Service, Technical Services, Controlled Substance Compliance, New Product Introduction, Quality Control, and Quality Assurance groups.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Coordinates bulk and aliquot inventory of reference standard compounds: Ensures proper labeling, organization, and storage of bulk and aliquot inventory. Completes quarterly forecasting of consumption and customer needs to evaluate secure supply, and notifies management of shortages. Ensures labeling and inventory control complies with Controlled Substance Compliance regulations. Picks items from stock or identifies items to be packaged for pending shipments. Completes packaging as needed prior to shipment date. Maintains inventory of necessary inventory and shipping supplies.
Coordinates domestic and international shipments to support reference standards orders and customer samples for Scientific Affairs and Technical Services and ensures all shipments are in accordance with regulatory and company guidelines: Monitors SAP for orders and coordinates with Customer Service (US and OUS). Reviews customer orders and DEA paperwork for accuracy and compliance. Coordinates appropriate shipping companies for domestic and export shipments. Completes all required documentation and completion of all associated SAP transactions. Transports outgoing shipments to the designated pick-up location. Coordinates all outgoing and incoming shipment paperwork and forwards to Controlled Substance Compliance department. Coordinates with various departments to resolve issues.
Completes functions of Analytical Chemist as needed to support the Reference Standards Program and other Scientific Affairs projects: Assists in performing analytical chemistry work to ensure the identity, purity, quality and strength of materials, by following established test methods and procedures. Reviews analytical chemistry work to ensure testing and reported results for identity, purity, quality and strength of materials complies to the established test methods and procedures. Learns to effectively and accurately operate and maintain laboratory equipment (such as HPLC, GC, HPLC/MS, GC/MS, X-Ray Diffraction, Particle Size Laser Diffraction). Performs assigned scientific experiments and procedures, basic troubleshooting, and interpretation of spectra and data. Assists with writing and updating protocols, test methods, standard operating procedures, and reports. Become familiar with Noramco documentation and associated systems (such as DocSpace, Trackwise, eCoC, eLIMS, SAP). Maintains and provides notebooks, records, reports, action/check lists and documentation which are current, legible, readily understood, complete and accurate to insure compliance with established procedures and specifications, and are verifiable as required or requested. Provides solutions to problems of limited scope and complexity. Exercises judgment within defined policies and procedures to determine appropriate action. Consults more senior scientists and management as appropriate. Continuously looks for ways to simplify or improve products, services, systems, and processes to achieve business goals, e.g., improve yield, cycle time, quality, and productivity. Performs other appropriate duties as assigned by the Reference Standards Program Lead.
ADDITIONAL POSITION REQUIREMENTS
Interfaces routinely with customer service, controlled substance compliance, external customers, and other internal laboratory personnel.Requires general understanding of the purpose for test methods, standard operating procedures, and sample handling and documentation practices typical in a lab environment.General understanding and knowledge of computerized data acquisition, analysis and handling techniques to ensure reliable, prompt, precise and accurate test data using established methods and procedures.Maintains an adequately supplied, properly cleaned and safe laboratory to minimize test delays, test errors and mishaps by using good laboratory and housekeeping practices.Ability to make decisions within specific guidelines and to work under direct supervision of more senior Scientists or Program Lead.Maintain and comply with all regulatory programs and guidelines to ensure that all current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) requirements are met.
Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority. Follows all applicable aspects of the site Environmental Management System as it pertains to normal job duties. Assumes responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise. Complies with all regulatory and job training requirements to perform duties of the job. Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), plus all other relevant job requirements. Must be available for overtime work on a scheduled or emergency basis..
Qualifications
Qualifications
A minimum of Bachelor’s in Chemistry or related science. A minimum of18 months of related experience in instrumental and wet chemical techniques is required (College lab work and educational lab work applies). Familiarity with cGMP/cGLP regulations and practices preferred. Experience with distribution, shipping or material movement is preferred. Experience using computerized inventory management systems, i.e. SAP is preferred. Must be able to qualify for respiratory protective equipment use, and must be able to smell surrounding environments. Exposure to some of the following techniques is preferred: HPLC, HPLC Mass Spectrometry, GC, Particle Size Analysis, XRPD. Ability to read and interpret documents such as SOPs, operating and maintenance instructions and procedure manuals is required.
Primary Location:North America-United States-Georgia-Athens
Organization: Noramco, Inc. (6109)
Job Function: R&D
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