Quality Control Chemist - Wilmington, United States - Noramco, Inc

Description

Specialists in controlled substance development and manufacturing, Noramco is a partner to the pharmaceutical industry:

• Delivering DEA-compliant security and production capacity, from kilos to multi-ton supply
• Highpurity controlled substances from narcotic raw materials
• Formulationfriendly particle size grades and extended technical packages
• Supporting worldclass supply security of controlled substances, from schedule I to schedule III

GENERAL PURPOSE OF JOB
Provides technical laboratory expertise to lab personnel and sets the testing priorities for an assigned laboratory shift.

Must be knowledgeable on all instrumental and wet chemistry methods pertinent to Noramco Quality Control to ensure timely analysis cycle times and complete any instrument or situation troubleshooting.

Ensures that the analysts are performing all duties in compliance with company and regulatory standards. Reviews analytical data and releases materials per applicable procedures and specifications. Investigates deviations and non-conformances and recommends appropriate actions to resolve. Acts as a technical resource for daily interactions with QC laboratory personnel. Secondary functions involve supporting lab improvement projects, method validations, stability analysis, and equipment qualifications. Some analytical testing may be performed to assist the shift analysts as needed.


ESSENTIAL DUTIES AND RESPONSIBILITIES

• Reviews analytical data following method procedures and product specifications to release assigned materials for further processing in a complete and accurate manner.
• Responsible for understanding the instrumental and wet chemistry methodology to thoroughly troubleshoot, perform root cause analysis for lab investigations, prioritize work assignments and assist the analysts with testing as needed.
• Ensures that lab personnel follow approved standard operating procedures.
• Conducts weekly shift meetings and escalates issues to supervision
• Provides technical expertise to internal customers (i.e. crossfunctional departments) and other lab personnel.
• Interacts with internal operations and other technical personnel, as well as contract laboratories as necessary.
• Perform and document stability pulls as assigned.
• Assures accurate and timely input of QC data to information systems: e

g:
SAP, Intellitrack, etc.

• Demonstrates focus and attention to details (i.e. Right First Time) in all aspects of the responsibilities.
• Conduct thorough lab investigations utilizing root cause analysis followed by written reports for nonconformance events.
• Coordinates and performs calibration of new laboratory instruments and equipment to ensure reliable, prompt, precise and accurate test data as directed.
• Troubleshoots and performs minor maintenance/repair of lab instruments. May coordinate and oversee external vendors during the repair of laboratory instruments for minor maintenance as assigned.
• Responsible for the setup, IQ, OQ and PQ of new instrumentation and equipment in the QC laboratory as assigned.
• Maintain an adequately supplied, properly cleaned and safe analytical chemistry laboratory to minimize test delays, test errors and mishaps by using good laboratory and housekeeping practices.
• Review and revise existing SOP's and other lab documents as necessary.
• When applicable, adapt existing methodologies to support manufacturing and new products
• Train laboratory personnel as it relates to specific operations and procedures by instruction and demonstration.
• Maintain regulatory required documentation, which is current, legible, readily understood, complete and accurate to ensure compliance with procedures and specifications.
• Supports short and long term projects meeting established deadlines. Responsible for leading and sustaining various projects as assigned.
• Perform other appropriate duties as assigned by the QC Supervisor.
• Must be willing to work a flexible schedule to support shift operations.

ADDITIONAL POSITION REQUIREMENTS

• Complete understanding and working knowledge of all test methods, procedures, instruments and apparatus for the receipt, labeling, sampling, testing, documentation, release and distribution of all chemical substances associated with Noramco, Inc.
• Complete understanding and working knowledge of computerized data acquisition, analysis and handling techniques to ensure reliable, prompt, precise and accurate test data using established methods and procedures.
• Successfully completes regulatory and job training requirements.
• Performs housekeeping 5S audits to assure lab is continuously maintained in a safe and orderly condition.
• Remains current in profession and industry trends.
• Makes a positive contribution through demonstration of ability to improve upon current laboratory practices and quality systems and through ability to learn new skills, procedures and processes.
• Carries out duties in compliance with all state and federal regulations a