QC Bioassay Associate

Title: QC Bioassay Associate
Location: Norwood, MA 
Pay: $30-37/hr - based on shift and experience
Contract: 6+ months 

Job Summary

In this role the QC Bioassay Associate will support in-process and release testing for raw materials, drug substance and mRNA drug products produced at Moderna's manufacturing facilities and affiliated contract organizations. Additionally, this position will assist management in ensuring the goals and milestones are met for the QC Bioassay Lab as well as day-to-day operations.

Job Responsibilities

• Utilize knowledge and investigations skills to identify and resolve issues and drive continuous improvement initiatives in laboratory operations
• Support Testing for Raw Materials, Drug Substance and drug product, including generation of testing data in support of commercially approved products and clinical studies
• Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
• Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities, including sequencing and qPCR assays as required
• Conduct technical assessments of deviations and investigations ensuring day to day operations are successful
• Perform on the job (OJT) training and act as mentor to QC Bioassay staff
• Assist in equipment qualification/Validation activities, including maintenance
• Assist with scheduling and resource allocation including Tier meetings as needed
• Represent the QC Bioassay team in the absence of management
• Work directly with management to ensure QC Goals and milestones are met
• Lead and organize continuous improvement projects
• Troubleshoot issues related to equipment, laboratory procedures and assay performance
• Write/revise SOP's, technical protocols, and reports
• Assist with audit preparation and regulatory compliance
• Responsible for responding to and addressing CTU alarms
• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement
• Follow all relevant GxP Regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOP's) and work instructions
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
• Complete training and assigned required learning plans accordingly to the defined due dates and prescribed requalification cadence.

Education & Qualifications 

• BS in a relevant scientific discipline (Biochemistry)
• Experience: 2-4 years of experience
• Demonstrated aptitude or ability to learn: Able gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards and guidances