QC Analytical Associate II

3 weeks ago

Mahwah NJ United States Joulé Full time

Title: QC Analytical Associate II
Location: Mahwah, NJ area
Schedule: Tuesday to Saturday ( 2:30 pm to 11 pm)
Type: Contract to Hire

Responsibilities:
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
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 Office
Visio


Strong 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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