Position: QC Associate III/Senior QC Associate
A position is immediately available for a Quality Control (QC) Associate III /Senior QC Associate to lead the stability program and sample management and perform QC testing, data analysis, OOS investigations, environmental monitoring, and assay qualifications/validations. The incumbent will also collaborate with the development group in developing new assays and analytical methods. Products may include cells, exosomes, and other regenerative therapeutics. We are seeking highly motivated candidates who are capable of independent work in a collaborative environment.
Responsibilities:
Establish and lead the stability program for new and existing products
Establish and lead sample management
Write technical reports or documentation such as deviations, qualification/validation protocols, and investigation of OOS results
Collaborate with Research and Product Development Department to troubleshoot and optimize current assays and future analytical methods
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
Manage relationships with outsourced laboratories to coordinate sample receipt, testing, and on time reporting of results
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
Perform data analysis, organize records, reports and databases in a timely manner
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 under minimal supervision to meet project goals
Present data internally
Receive and inspect materials
Other duties as assigned
Requirements:
5+ years of experience working in a GMP Quality Control laboratory or a combination of experience in a GMP/GLP setting is required
Experience with mammalian cell culture methods and molecular biology skills
Expertise with laboratory methods including flow cytometry, qPCR, RNA/DNA isolation, ELISA, endotoxin detection etc
Experience with method qualification/validation is desired
The ability to independently perform laboratory analysis, troubleshoot, and improve methods
A history of successful, independent laboratory work
Excellent communication, time-management skills and the ability to work as part of a team are required
Excellent project management and organizational skills
Strong ability to lead teams and manage QC specialties, stability program, sample management
Operational Excellence skills, eg 5S, lean, desired
Computer literate. Ability to work with Outlook, MS Office, and other electronic systems
Ability to gown and work in a classified area. Aseptic processing a plus
A Bachelor’s degree in a relevant Biological Science discipline is required