Scientist II - # 26-25896

Us Tech Solutions; Irvine (CA); In loco; USD 62.000 - 65.000; Tempo pieno

Descrizione del lavoro

US Tech Solutions in Irvine, CA seeks a laboratory scientist for contract work performing cGMP cell-based potency assays in support of biologics manufacturing. The role includes data generation, review of raw data, cell culture, and management of reagents in a regulated setting.

The incumbent will ensure EHS and quality systems compliance, contribute to SOPs, and assist with regulatory inspections while maintaining documentation integrity and lab equipment calibration.

Competenze

• MS in Chemistry/Biochemistry/Cell Biology or related field with 3+ years of industrial experience or BS with 5+ years of industrial experience.
• Proficiency in quality systems, Microsoft Project, and Excel.
• Experience in a GMP regulated environment.
• Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred.
• Experience with aseptic cell culture and cell banking preferred.

Mansioni

• Perform cGMP cell-based potency assays in support of biologics manufacturing.
• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
• Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections where needed.
• Ensure that lab equipment is used and maintained; support validation and preventive maintenance.
• Generate and update SOPs.
• Adhere to EHS standards and policies.
• Maintain and ensure laboratory data integrity in documentation and computerized systems.

Conoscenze

Quality systems

GMP experience

Cell culture

ELISA / Chemi-ECL

PCR

Automation

Aseptic technique

Formazione

MS in Chemistry/Biochemistry/Cell Biology (3+ years)

BS in Chemistry/Biochemistry/Cell Biology (5+ years)

Strumenti

Microsoft Project

Excel

Automation software

Descrizione del lavoro

$45-$47 per hour

Irvine, CA

Contract

Duration: 12+ Months Contract

Major Responsibilities:

• Perform cGMP cell-based potency assays testing in support of the manufacture of client’s biologics products. Responsible for the timely completion of assigned laboratory testing.

• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies .

• Review and approve raw data and laboratory logbooks/worksheets.

• Perform cell culture and cell banking .

• Manage critical reagents and supplies.

• Write quality systems records including laboratory investigations, change controls, non-conformances .

• Support regulatory inspections where needed.

• Ensure that all lab equipment is used and maintained correctly. Support lab equipment validation and equipment preventive maintenance.

• Generate and update SOPs.

• Adhere to and supports all EHS standards, procedures and policies.

• Understand regulations and business processes required to maintain laboratory data integrity.

• Maintain and comply with laboratory documentation and computerized systems data integrity requirements.

Regulated Responsibilities (including cGMP and EHS):

• Client is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

• Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications:

• MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.

• Proficiency in quality systems, Microsoft Project, and Excel.

• Experience in a GMP regulated environment.

• Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred.

• Experience with aseptic cell culture and cell banking preferred.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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