QC Analytical Associate I

Title:  Quality Control Analytical Associate I
Location:  Mahwah, NJ area
Schedule:  1st Shift 6 AM- 2:30 PM Tues to Saturday OR Sunday to Thursday
Type:  Contract to Hire

Responsibilities:
The Quality Control Analytical Associate serves as a support role to clinical and commercial production. The QC Analytical Associate 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 I 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
• 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 and equipment 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.
• Additional tasks as assigned.

Requirements: 

• BA/BS in a science or relevant field required
• Prior cGMP experience preferred
• Prior academic and/or industrial cell therapeutic experience preferred
• Minimum 0-2 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry
• Basic Laboratory Equipment , Cell count, flow cytometry (nice to have) ,CBC, documentation
• Proficient with computer software such as
• Microsoft Office
• Visio

Strong written and oral communication skills

Strong presentational skills preferred

Build Quality into all aspects of your work by maintaining compliance to all quality requirements.

Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).

Attend all required Quality & Compliance training at the specified interval.

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.