Scientist II - # 26-25896

Us Tech Solutions; Irvine (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

US Tech Solutions in Irvine, CA is seeking a GMP-lab Scientist to perform cell-based potency assays in support of the manufacture of client’s biologics and ensure timely completion of testing.

You will generate, compile and evaluate data for technical reports, review raw data and laboratory logbooks, perform cell culture and cell banking, manage reagents, and write quality systems records while adhering to EHS standards and regulatory requirements.

Qualifications

• MS or BS with 3+ / 5+ years of relevant industrial experience in a GMP environment.
• Proficiency with quality systems, data integrity, and laboratory recordkeeping.

Responsibilities

• Perform cGMP cell-based potency assays for biologics manufacturing.
• Generate, compile, and evaluate data for technical reports.
• Review and approve raw data and lab notebooks.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including investigations and change controls.
• Support regulatory inspections and maintain lab equipment and validation.
• Generate and update SOPs and ensure EHS compliance.

Skills

GMP experience

Education

MS in Chemistry/Biochemistry/Cell Biology

BS in Chemistry/Biochemistry/Cell Biology

Tools

Microsoft Project

Excel

Job description

• 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.

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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