Scientist II

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

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