Analytical Chemist

QC Analytical Laboratory Scientist

Contract: 2 Years
Work Location: 100% Onsite
Schedule: Monday–Friday with flexibility for overtime, weekends, holidays, and non-standard hours as required by the manufacturing schedule.

Position Overview

We are seeking an experienced QC Analytical Laboratory Scientist to support cGMP routine testing within a pharmaceutical/biopharmaceutical manufacturing environment. This role will perform analytical testing, support laboratory investigations and quality-system activities, and ensure testing and documentation meet GMP, regulatory, and data-integrity requirements.

Key Responsibilities

• Perform routine QC testing using HPLC, Gas Chromatography (GC), Capillary Electrophoresis (CE), and UV analysis.
• Complete chemical and laboratory testing accurately and within required timelines.
• Support and own quality-system records related to OOS results, deviations, laboratory investigations, CAPAs, and Change Controls.
• Maintain accurate, complete, and compliant laboratory records and documentation.
• Ensure laboratory data integrity and compliance with computerized system requirements.
• Support method transfers, method validations, and new product transfers.
• Author and review SOPs, protocols, reports, test methods, and other laboratory documents.
• Support qualification, maintenance, and proper use of laboratory equipment.
• Complete in-process sampling and testing according to manufacturing schedules.
• Assist with troubleshooting and resolution of laboratory and quality issues.
• Maintain laboratory inventory and support routine laboratory activities, including waste disposal, glasswasher, and autoclave operations.
• Follow all cGMP, EHS, and company procedures and policies.
• Work in regulated BSL-2/BSL-3 and select-agent/toxin-controlled areas as required.

Required Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 3 years of laboratory experience, preferably within pharmaceutical or biopharmaceutical manufacturing.
• Hands-on experience with HPLC and Gas Chromatography (GC).
• Experience working in a GMP/cGMP-regulated laboratory environment.
• Experience with OOS investigations, deviations, CAPA, and Change Control.
• Strong understanding of laboratory documentation and data integrity requirements.
• Ability to work independently, manage multiple priorities, and meet testing deadlines.
• Strong written and verbal communication skills with excellent attention to detail.

Preferred Qualifications

• Experience with Capillary Electrophoresis (CE) and UV/UV-Vis analysis.
• Experience with analytical method validation and method transfer.
• Experience qualifying and maintaining laboratory equipment.
• Experience with LIMS or computerized laboratory systems.
• Experience in pharmaceutical/biopharmaceutical QC or manufacturing.
• Experience with environmental monitoring or sterile/aseptic manufacturing.
• Experience working in BSL-2/BSL-3 laboratories or with select agents/toxins.
• Knowledge of ALCOA+ and laboratory data integrity principles.

Work Environment Requirements

• This is a 100% onsite laboratory position.
• Must be able to work overtime, weekends, holidays, and occasional non-standard hours based on manufacturing needs.
• Must be able to wear a respirator for extended periods when required.
• Role involves regular movement, including lifting/carrying equipment, pushing carts, and performing environmental monitoring activities.
• Must comply with all applicable requirements governing access to select agents and toxins.

Pay: $24.00 - $26.00 per hour

Expected hours: 40.0 per week

Benefits:

• Health insurance

Education:

• Bachelor's (Preferred)

Experience:

• analytical lab: 3 years (Preferred)
• HPLC and Gas Chromatography (GC).: 3 years (Preferred)
• Capillary Electrophoresis (CE) and UV/UV-Vis analysis.: 3 years (Preferred)
• LIMS: 3 years (Preferred)
• analytical method validation and method transfer.: 3 years (Preferred)
• GMP: 3 years (Preferred)

Ability to Commute:

• Irvine, CA 92614 (Preferred)

Work Location: In person