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.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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Numbers & Facts
Location
Irvine, CA
Skills
Americans with Disabilities Act (ADA)unmatched
Asepsisunmatched
Assaysunmatched
Automationunmatched
Banking Servicesunmatched
Biochemistryunmatched
Biological Assayunmatched
Biologyunmatched
Business Practicesunmatched
Business Processesunmatched
Cell Biologyunmatched
Cell Culturesunmatched
Change Controlunmatched
Chemistryunmatched
Corporate Complianceunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Data Collectionunmatched
Data Qualityunmatched
Documentationunmatched
Environmental Complianceunmatched
Environmental Healthunmatched
Environmental Protection Agency (EPA)unmatched
Equipment Maintenance/Repairunmatched
Equipment Validationunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Laboratory Equipmentunmatched
Laboratory Testingunmatched
Medical Equipmentunmatched
Medical Productsunmatched
Microsoft Excelunmatched
Microsoft Projectunmatched
OSHAunmatched
Polymerase Chain Reaction (PCR)unmatched
Preventative Maintenanceunmatched
Regulationsunmatched
Safety Trainingunmatched
Safety/Work Safetyunmatched
Sarbanes-Oxley Act (SOX)unmatched
Standard Operating Procedures (SOP)unmatched
Technical Supportunmatched
Testingunmatched
Time Managementunmatched
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