To Discuss more about this job opportunity, please reach out to Anwesha Mohapatra (LinkedIn URL

• Anwesha Mohapatra
• Collabera | LinkedIn ), email your updated resume at Email
• anwesha.

mohapatra@collabera.com . Thank you!

Pay Range:

$40/hr to $45/hr

Job Title:

Scientist II Location:

Irvine, California 92612

Work Type:

Onsite Contract Duration:

24 Months, with possible extension based on performance and business needs

Job Summary:

We are seeking a skilled Scientist II to perform analytical laboratory testing within a pharmaceutical manufacturing environment. The ideal candidate will have hands on experience with HPLC, Gas Chromatography, and Capillary Electrophoresis, along with a strong understanding of current Good Manufacturing Practices and laboratory data integrity. This role involves routine chemical testing, laboratory investigations, quality system documentation, and analytical method validation and transfer. The successful candidate will support laboratory equipment qualification, maintain accurate records, and ensure compliance with applicable regulatory and safety standards. Candidates must be flexible to work overtime, weekends, holidays, and alternate hours based on manufacturing requirements.

Key Responsibilities:

Perform timely chemical and laboratory testing in accordance with approved procedures and applicable cGMP requirements. Maintain accurate, complete, and traceable laboratory records while ensuring compliance with data integrity requirements and computerized laboratory system procedures. Own and support quality system records related to deviations, laboratory investigations, Corrective and Preventive Actions, and Out of Specification results. Operate, maintain, and support the qualification of laboratory equipment to ensure reliable and compliant performance. Conduct in process sampling and testing within established timelines to support manufacturing operations. Participate in analytical method transfers, method validations, and new product transfer activities as required. Author, review, and update laboratory protocols, reports, test methods, and Standard Operating Procedures. Assist in resolving laboratory quality issues and implementing appropriate corrective actions. Perform routine laboratory activities, including waste disposal, glassware washing, and autoclave operations. Maintain accurate inventory records for controlled toxins and follow applicable access, handling, biosafety, and regulatory requirements. Follow environmental, health, safety, and environmental standards, procedures, and policies. Support environmental monitoring activities involving physical movement, equipment handling, and the use of respiratory protection when required.

Required Qualifications:

Bachelor's degree in a scientific discipline with three to five years of laboratory experience. Hands on experience with High Performance Liquid Chromatography, Gas Chromatography, and Capillary Electrophoresis. Working knowledge of UV analysis and general chemistry laboratory testing. Experience working in a cGMP regulated pharmaceutical or related laboratory environment. Experience with laboratory investigations, Corrective and Preventive Actions, and Change Control. Knowledge of laboratory documentation practices, data integrity requirements, and computerized laboratory systems. Ability to work independently, manage competing priorities, and deliver accurate results under pressure. Strong written and verbal communication skills with excellent attention to detail. Ability to wear a respirator for extended periods, perform physical laboratory tasks, and work in designated biosafety environments when required. Flexibility to work overtime, weekends, holidays, and alternate hours based on manufacturing schedules.

Preferred Qualifications:

Experience supporting analytical method validation and method transfer activities. Experience authoring and reviewing laboratory protocols, analytical reports, test methods, and Standard Operating Procedures. Experience with laboratory equipment qualification and maintenance. Familiarity with Biosafety Level II and Biosafety Level III laboratory procedures and controlled toxin inventory management. Previous experience supporting pharmaceutical manufacturing and laboratory quality systems.

Benefits :

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually

• AS Applicable)