Quality Control Analyst - Reference Standards

We are looking to fill a Quality Control Analyst position with a Monday-Friday, 8am-4 : 30pm schedule.

As a QC Analyst, a typical day might include the following :

• Responsible for QC Reference Standard and Materials processes, including qualification, re-qualification, implementation, and stability monitoring of product reference standards and qualified materials used in QC testing.
• Set and maintain internal requirements for product reference standards.
• Ensure timely procurement and implementation of product reference standards and qualified materials.
• Own and complete Change Controls to support QC Materials processes (often several at once).
• Provide program and lifecycle management for product reference standards and qualified materials.
• Create and revise high-level documentation, including Technical Documents, Standard Operating Procedures (SOPs), Certificates of Qualification, Primary Qualification Reports, and Biologics License Applications (BLA).
• Serve as a representative for the QC Materials team in cross-functional meetings.
• Be responsible for and maintain appropriate inventory levels of product reference standards and qualified materials.
• Work with members of QC Labs, Tarrytown, and Business Partners for reagent and product reference standard forecasts.
• Support sub-aliquotting, shipping, inventory, and handling of reference standards and qualified materials.
• Provide excellent customer service to partners and laboratories.
• Evaluate, document, and support investigation of deviations in the appropriate Quality System.
• Demonstrate outstanding time management, prioritization, written and oral communication, presentation, and organization skills.
• Prepare and provide regular data updates and deliverables to management and group.
• Lead and coordinate the improvement effort of streamlining processes.
• Adhere to cGMP policies, procedures, and training.

This role might be for you if :

• You have a strong attention to detail
• You have good interdepartmental communication skills
• You can multi-task on several projects simultaneously

To be considered for the QC Analyst position you must be willing and able to work a Monday-Friday 8am-4 : 30pm schedule.

Various levels require the following :

• Associate QC Analyst : BS / BA in Life Sciences, or related field, or an equivalent combination of education and experience.
• QC Analyst : BS / BA in Life Sciences, or related field, and a minimum of 12-18+ months of related experience; or an equivalent combination of education and experience.
• Sr. QC Analyst I : BS / BA in Life Sciences, or related field, and 4+ years of experience; or an equivalent combination of education and experience.
• Level is determined based on qualifications relevant to the role.
30+ days ago