Scientist II

The Fountain Group; Irvine (CA); On-site; USD 62,000 - 69,000; Full time

Job summary

The Fountain Group is seeking a Scientist II for a client in Irvine, CA. This 2-year onsite role pays $45–$50 per hour and requires hands-on laboratory experience in a regulated environment.

Responsibilities include performing routine chemical testing with HPLC, GC, CE, and UV, maintaining data integrity, and supporting deviations and CAPAs. Flexibility for overtime and respirator use is required.

Qualifications

• Bachelor’s degree in Chemistry or related field.
• 3–5 years of laboratory experience in a regulated setting.
• Hands-on HPLC methods experience.
• Experience with GC, CE, and UV analysis.
• Experience in a cGMP-regulated lab environment.
• Ability to support investigations, deviations, CAPAs, and OOS.
• Strong data integrity and documentation practices.
• Ability to work independently and meet deadlines.

Responsibilities

• Perform routine chemical and laboratory testing accurately and on time.
• Conduct analyses using HPLC, GC, CE, and UV methods.
• Ensure compliance with cGMP, records, and data integrity.
• Own and support records for deviations, CAPAs, and OOS results.
• Complete in-process sampling and testing per schedules.
• Maintain accurate laboratory records and test documentation.
• Operate, maintain, and qualify laboratory equipment.
• Participate in method transfers, validations, and equipment qualifying.
• Author and review lab documents including SOPs.
• Assist in resolving lab/quality issues and support product transfers.
• Perform routine duties: waste disposal, glassware washing, autoclaves.
• Maintain toxin inventory per regulatory/site requirements.
• Follow EHS policies and work in designated safety areas (BSL-2/3).

Skills

HPLC Analytical Testing

Gas Chromatography

Capillary Electrophoresis

UV Analysis

cGMP-Regulated Lab Experience

Laboratory Investigations

CAPA & OOS

Data Integrity & Documentation

Independent Work Ethic

Strong Organizational Skills

Education

Bachelor’s degree in Chemistry

Tools

HPLC

GC

CE

UV analysis

Job description

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