Senior Scientist, Quality Control, Compendial

this opportunity•Irvine, CA

About The Position

About this opportunity : Support the daily operations of the Quality Control Department by performing, often complex, elemental analysis of raw materials, drug substance, drug product and components in accordance with cGMP requirements, company policies and procedures as directed by laboratory management.

Requirements

A minimum of 12 years, 14+ years preferred, industry related work experience.
Bachelor's degree or equivalent in scientific discipline required. Advanced degree is strongly preferred.
Advanced knowledge of elemental analysis in raw materials, drug substance, drug product and components.
Advanced knowledge of analytical chemistry principles and techniques using Atomic Absorption (Flame and Graphite Furnace), Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) and Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES)
Advanced knowledge of USP, Pharm. Eur. and other compendial methods and procedures with emphasis on USP <232>, <233>, Pharm. Eur. <2.4.20>, <2.2.57>, <2.2.58>, JP <5.20>, <2.63>, <2.66>
Proficient in method development and phase appropriate validation in compliance with ICH guidelines, FDA regulations, compendia and cGMP requirements
Strong technical writing skills for protocols, test methods, reports, laboratory investigation and deviations according to applicable methodologies/regulations.

Responsibilities

Perform, often complex, elemental analysis of raw materials, drug substance, drug product, and components according to established specifications and procedures using elemental analysis techniques (ICP-MS, ICP-OES, AA) in accordance to USP, Pharm. Eur. and other compendial methods per Customer, Company, and cGMP requirements.
Assume ownership of assigned quality documentation, such as investigations, 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.
Compose test methodologies, study protocols, and Standard Operating Procedures in order to 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 problems complex in nature where analysis of situations or data requires in-depth review and evaluation of various factors, considerable judgment is required in resolving problems and making routine recommendations. Exercise judgment within broadly 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.
Recommend equipment, facility, and process improvements to your supervisor.
Maintain clear, accurate and traceable documentation records to ensure compliance with Good Documentation Practices (GDP).
Maintain laboratory and workspace cleanliness by adhering to the 5S method of organization.
Abide by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.