Laboratory Technician Ii Hplc Gc Cgmp Operations

Laboratory Technician II – HPLC & GC (cGMP Operations)
Location: Irvine, CA | 100% onsite Length of Assignment: 2 years Pay Rate: $23-26/hr (medical benefits available at a cost)
Schedule: Overtime, weekends, holidays, and nonstandard hours as needed to support the manufacturing schedule.
Job Description The Lab Tech II performs chemical and laboratory testing in a cGMP-regulated environment, maintains accurate laboratory records and data integrity, and supports quality investigations, method transfers, validations, and equipment qualification.
The position involves work with select agents and toxins in biosafety level 2 and biosafety level 3 laboratories. Access to and use of select agents are regulated by federal policies. All activities must comply with internal policies and applicable regulatory requirements.
The work environment requires wearing a respirator during production for at least four hours. The role involves constant physical movement, including lifting and carrying equipment during environmental monitoring and pushing carts and doors.
Understand the regulations and business processes required to maintain laboratory data integrity. Comply with laboratory documentation and computerized-system data integrity requirements.
Complete chemical and laboratory testing, including in-process sampling and testing, within required timelines.
Use and maintain test equipment correctly and support qualification of new laboratory equipment.
Maintain up-to-date, complete, and precise records of all testing performed and adhere to cGMP requirements.
Own and support routine cGMP testing and the associated quality-system records for deviations, laboratory investigations, corrective and preventive actions (CAPAs), and out-of-specification (OOS) results. Assist in resolving quality problems.
Develop and update in-house laboratory procedures, and author and review protocols, reports, test methods, and standard operating procedures (SOPs).
Support new-product transfers and participate in method transfers and validations as needed.
Apply knowledge of high-performance liquid chromatography (HPLC), gas chromatography (GC), capillary electrophoresis (CE), and ultraviolet (UV) analysis.
Adhere to and support all environmental, health, safety, and energy (EHS & E) standards, procedures, and policies.
Perform daily laboratory activities, including waste disposal, glasswasher operation, and autoclave runs.
Maintain accurate toxin inventory records during usage.
Qualifications Knowledge of gas chromatography (GC).
Experience using HPLC analytical methods and essential general chemistry knowledge for the chemistry laboratory.
Knowledge of capillary electrophoresis (CE).
Bachelor’s degree in a scientific field, with a minimum of three years of laboratory experience.
Experience working in a GMP-regulated environment.
Experience with laboratory investigations, CAPA, and change control, including ownership of quality-system records supporting routine cGMP testing.
Ability to work overtime, weekends, holidays, and nonstandard hours as required by the manufacturing schedule.
Ability to work in the stated laboratory environment, including required respirator use and physical activities.
Clear communication with colleagues, peer groups, and managers.
Demonstrated ability to work independently and autonomously when required.
Attention to detail and the ability to plan and schedule workloads.
Ability to work well under pressure, consistently deliver results, and take action to overcome obstacles.
Relevant industry experience preferred.
People are our business worldwide Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.