Quality Control Associate 1 Or 2

Position: Quality Control Associate I/II

We are seeking highly motivated candidates who are capable of independent work in a collaborative environment for a Quality Control Associate I/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
• Interface with outsourced laboratories to coordinate sample receipt, testing, and on time reporting of results
• Prepare and maintain mammalian cell cultures
• Perform data analysis, organize records, reports and databases in a timely manner
• Write technical reports or documentation such as deviations, qualification/validation protocols, and investigation of OOS results
• Collaborate with Process/Analytical Development to troubleshoot and optimize current assays and future analytical methods
• Train other employees to perform relevant techniques and procedures as needed
• 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 closely with the Manufacturing and Quality Assurance department staff to resolve issues regarding the facility and products manufactured
• Present data internally
• Receive and inspect materials
• Work under minimal supervision to meet project goals; and
• Other duties as assigned

Requirements:

• Bachelor’s degree in a relevant Biological Science discipline
• 2+ 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