QC Associate II

Job Title: QC Associate II

Job Number: 35664

Location: San Diego, CA

Job Description

We are seeking highly motivated candidates who are capable of independent work in a collaborative environment for a Quality Control Associate II. This position will need to perform QC testing of existing products, coordinate shipping of samples for outsourced testing, perform data analysis, assemble and complete QC data documentation, perform OOS investigations, and assay qualifications. This position will also collaborate with the development group in developing new assays and analytical methods. Products may include cells, exosomes, and other regenerative therapeutics.

Responsibilities

• Perform QC analysis testing on current products to support batch disposition, including testing on in-process intermediates, final formulated bulk drug substance and final drug product
• Collaborate with Research and Product Development Department to troubleshoot and optimize current assays and future analytical methods
• Work closely with the Manufacturing and Quality Assurance department staff to resolve issues regarding the facility and products manufactured
• Prepare and maintain mammalian cell cultures
• Write or revise quality control Standard Operating Procedures
• Carry out Environmental Monitoring of manufacturing facility and relevant samples generated
• Coordinate with third party vendors to maintain calibration of equipment
• Work under minimal supervision to meet project goals
• Present data internally
• Receive and inspect materials

Required Skills

• Bachelor’s degree in a relevant Biological Science discipline 
• 3+ years of experience working in a GMP Quality Control laboratory or a combination of experience in a GMP/GLP setting is preferred
• Mammalian cell culture methods and molecular biology skills
• Experience with laboratory methods including flow cytometry, Western Blot, qPCR, RNA/DNA isolation, ELISAs, endotoxin detection etc
• Experience with method qualification/validation is preferred
• The ability to independently perform laboratory analysis, troubleshoot, and improve methods
• Demonstrated history of successful, independent laboratory work
• Excellent communication, time-management skills and the ability to work as part of a team
• Ability to work with Outlook, MS Office, and other electronic systems
• Ability to gown and work in a classified area. Aseptic processing a plus

Salary range: $72,000-95,000K

Benefits:
Health Insurance (medical, dental, vision)
Life Insurance
Short- and Long-Term Disability
401(k)
Paid Time Off