Nitto Avecia Pharma Services ยท 1 day ago
Senior Scientist, Quality Control, Compendial
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$92K/yr - $143K/yr
12+ years expNitto Avecia Pharma Services is a company focused on pharmaceutical services, and they are seeking a Senior Scientist in Quality Control. The role involves performing complex elemental analysis and ensuring compliance with cGMP requirements while managing quality documentation and laboratory operations.
BiotechnologyHealth CareMedical DevicePharmaceutical
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
Qualification
Required
A minimum of 12 years, 14+ years preferred, industry related work experience
Bachelor's degree or equivalent in scientific discipline required
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, Pharm. Eur., JP
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
Preferred
Advanced degree is strongly preferred
Company
Nitto Avecia Pharma Services
Nitto Avecia Pharma Services is your single source for analytical services for the pharma, biotech, and medical device industries.
51-200 employees
H1B Sponsorship
Nitto Avecia Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2016-10-11Acquired
Recent News
Orange County Business Journal
2025-11-09
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2025-10-31
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