System One
QC Analytical Associate II
System One, Mahwah, New Jersey, us, 07495
Title:
QC Analytical Associate IILocation:
Mahwah, NJ areaSchedule:
Tuesday to Saturday (2:30 pm to 11 pm)Type:
Contract to HireResponsibilities:The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical, responsibilities of the QC Analytical Associate II will include but are not limited to:Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations.Performs maintenance, monitoring, and troubleshooting of pertinent equipment.Performs and assists in the training of other Quality Control technicians.Maintains training records and coordinates records retention with Document Control and Training groups.Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines.Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable.Participates in managing QC materials and supplies.Performs and assists in equipment and method qualification/validation activities as needed.Performs reagent and media preparation.Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment.Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results.Initiates, investigates, and prepares deviation reports with input from assigned supervisor.Brainstorms and implements corrective and preventive actions, as and when applicable.Documents training and execution of shipping test samples to contract laboratories for testing.Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).Communicates effectively with other co-workers, departments, management and clients.Eventually serves as a lead and/or co-lead for client projects.Additional tasks as assigned.Requirements:BA/BS in a science or relevant field required.Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry.Prior cGMP experience required.Experience with GMP, Cell count, flow cytometry, documentation, flexibility, CBC, Endotoxin, ELISA, qPCR.Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred.Prior industrial experience in cell count methodologies preferred.Prior academic and/or industrial cell therapeutic experience preferred.Proficient with computer software such as:Microsoft OfficeVisioStrong written and oral communication skills.Strong presentational skills preferred.Benefits:System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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QC Analytical Associate IILocation:
Mahwah, NJ areaSchedule:
Tuesday to Saturday (2:30 pm to 11 pm)Type:
Contract to HireResponsibilities:The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical, responsibilities of the QC Analytical Associate II will include but are not limited to:Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations.Performs maintenance, monitoring, and troubleshooting of pertinent equipment.Performs and assists in the training of other Quality Control technicians.Maintains training records and coordinates records retention with Document Control and Training groups.Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines.Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable.Participates in managing QC materials and supplies.Performs and assists in equipment and method qualification/validation activities as needed.Performs reagent and media preparation.Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment.Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results.Initiates, investigates, and prepares deviation reports with input from assigned supervisor.Brainstorms and implements corrective and preventive actions, as and when applicable.Documents training and execution of shipping test samples to contract laboratories for testing.Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).Communicates effectively with other co-workers, departments, management and clients.Eventually serves as a lead and/or co-lead for client projects.Additional tasks as assigned.Requirements:BA/BS in a science or relevant field required.Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry.Prior cGMP experience required.Experience with GMP, Cell count, flow cytometry, documentation, flexibility, CBC, Endotoxin, ELISA, qPCR.Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred.Prior industrial experience in cell count methodologies preferred.Prior academic and/or industrial cell therapeutic experience preferred.Proficient with computer software such as:Microsoft OfficeVisioStrong written and oral communication skills.Strong presentational skills preferred.Benefits:System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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