Chemist III, Quality Control, Compendial, MAPS

Nitto Denko • Irvine, CA

16h

About The Position

Perform elemental analysis of raw materials, drug product and drug substance samples, in accordance with cGMP requirements, company policies and procedures as directed by laboratory management. This role involves performing routine laboratory analysis, reviewing and executing testing, recording and reviewing data, and exercising judgment within defined practices and policies. The position also requires assuming ownership of quality documentation and working effectively under pressure in a rapidly changing environment.

Requirements

• Bachelor's degree or equivalent in scientific discipline required.
• A minimum of 4 years, 6+ years preferred, industry related work experience.
• Developing knowledge of cGMP, FDA regulations, and ICH guidelines as they pertain to contract laboratory operations.
• Developing knowledge of USP, Pharm. Eur. and other compendial methods and procedures.
• Developing knowledge of Elemental Analysis through instruments such as Flame or Graphite Atomic Absorption, Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), Inductively Coupled Plasma Mass Spectrometry (ICP-MS).
• Developing knowledge in the use of LIMS and electronic documentation systems (i.e. MasterControl).
• Strong interpersonal skills.
• Must be able to express oral and written communication in a clear and concise manner and effectively present information and respond to questions from managers, customers and employees.
• Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed.
• Ability to work effectively under pressure in a rapidly changing environment.
• Ability to work well independently and effectively with a wide variety of colleagues both inter- and intra- departmentally.
• Ability to understand and apply technical concepts to laboratory operations developing solutions to problems that require ingenuity, creativity, and innovation.
• Ability to seek critical information from key resources to assist in problem solving.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, etc.).

Responsibilities

• Perform routine laboratory analysis of raw material, drug product and drug substance samples according to established specifications and procedures using analytical chemistry techniques and elemental analysis instrumentations in accordance with Customer, Company and cGMP requirements.
• Read and understand test methodologies, study protocols, and Standard Operating Procedures in order to review or execute testing in compliance with necessary policies and procedures.
• Record/review data in controlled notebooks, data sheets, and electronic systems (i.e. LIMS, etc.) in accordance with cGMP requirements.
• Work on routine tasks where analysis of situations or data requires review and evaluation of limited factors, limited judgment is required in resolving problems and making routine recommendations.
• Exercise judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Notify Supervisor of any discrepancy in laboratory testing or general laboratory operations.
• In case of any observed discrepancies, initiate and follow through with the required quality exception documentation as needed.
• Assume ownership of assigned quality documentation, such as exceptions, change controls, and CAPAs, ensuring that documentation is initiated and closed on time, required actions are thorough and meet procedural requirements as well as customer needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level