Scientist II Job Irvine California USA,Quality Assurance

The Fountain Group is currently seeking a Scientist II for a prominent client of ours. This position is located at Irvine, CA
. Details for the position are as follows:

Title:

Scientist II

Location:

Irvine, CA
Duration: 02 Years (With Possible Extension/Hire)
Pay : $45 - $50/ hours

Job Details:

The QC Chemistry Laboratory Analyst will be responsible for performing routine chemical and analytical testing in a cGMP-regulated environment. The role requires hands-on experience with HPLC, Gas Chromatography (GC), and Capillary Electrophoresis (CE), along with a strong understanding of laboratory data integrity, documentation, and quality systems. The individual will support laboratory investigations, deviations, CAPAs, out-of-specification (OOS) results, method transfers, validations, and equipment qualifications while ensuring compliance with applicable regulatory and safety requirements.

Key Responsibilities:

Perform routine chemical and laboratory testing accurately and within established timelines.
Conduct analytical testing using HPLC, Gas Chromatography (GC), Capillary Electrophoresis (CE), and UV analysis.
Ensure compliance with cGMP regulations, laboratory documentation standards, and computerized systems data integrity requirements.
Own and support quality system records related to deviations, laboratory investigations, CAPAs, and out-of-specification (OOS) results.
Complete in-process sampling and testing according to established schedules and manufacturing requirements.
Maintain accurate, complete, and up-to-date laboratory records and test documentation.
Ensure laboratory equipment is properly operated, maintained, and qualified.
Participate in method transfers, analytical method validations, and the qualification of new laboratory equipment.
Author and review laboratory documents, including protocols, reports, test methods, and Standard Operating Procedures (SOPs).
Assist in resolving laboratory and quality-related issues and support the development or revision of laboratory procedures.
Support new product transfers and ongoing ABL project activities.
Perform routine laboratory duties, including waste disposal, glassware washing, and autoclave operations.
Maintain accurate inventory and usage records for toxins in accordance with applicable regulatory and site requirements.
Follow all Environmental, Health, Safety, and Environmental (EHS&E) policies and procedures.
Work in designated Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3) laboratory areas, including areas requiring authorized access to select agents and toxins, while adhering to applicable federal regulations and internal procedures.

Required Qualifications:

Bachelor’s degree in Chemistry or a related scientific discipline.
3-5 years of laboratory experience, preferably in a pharmaceutical, biotechnology, or other regulated industry.
Hands-on experience with HPLC analytical methods and general chemistry testing.
Knowledge or experience with Gas Chromatography (GC), Capillary Electrophoresis (CE), and UV analysis.
Experience working in a cGMP-regulated laboratory environment.
Experience supporting laboratory investigations, deviations, CAPAs, and change control.
Strong understanding of laboratory documentation, data integrity, and quality system requirements.
Ability to work independently, manage priorities, and meet testing deadlines.
Strong attention to detail, organizational skills, and effective communication abilities.
Work Schedule and Physical Requirements
This is a 100% onsite position with no regular remote-work option.
Must be flexible to work overtime, weekends, holidays, and nonstandard hours as required by manufacturing schedules.
Must be able to work in environments requiring respirator use for at least four hours during production activities.
Must be able to perform physical tasks such as lifting and carrying equipment, pushing carts, opening doors, and supporting environmental monitoring activities.
Must comply with applicable access, safety, and handling requirements when working in controlled laboratory environments, including BSL-2 and BSL-3 areas.

Required Skills:

HPLC Analytical Testing
Gas Chromatography (GC)
cGMP-Regulated Laboratory Experience
Laboratory Investigations, Deviations, CAPA, and OOS
Laboratory Data Integrity and Documentation