QC Scientist

Responsibilities

Schedule:

Monday-Friday, 8:00 AM - 4:30 PM. Occasional off-shift hours, weekends, and holidays may be required to support manufacturing operations.

• Perform cGMP QC bioanalytical testing, troubleshooting, laboratory operations, equipment maintenance, data review, training, quality record management, method transfer support, and other departmental activities as assigned.
• Perform timely, Right First Time (RFT) cGMP testing and documentation for in-process (including STAT), release, stability, and critical utility (TOC/Conductivity) testing while following approved procedures and safe laboratory practices.
• Troubleshoot routine technical issues and support laboratory investigations as needed.
• Perform and troubleshoot routine and complex testing, including:
• TOC/Conductivity
• Compendial assays (appearance, pH, osmolality)
• FTIR
• A260
• Cell Count and Viability
• Viral Genome Titer (VGT) using ddPCR/qPCR
• Infectivity Assays (TCID
  50)
• icIEF/CE-SDS
• SDS-PAGE
• ELISA
• UHPLC
• Support method transfers, qualifications, validations, verifications, and troubleshooting activities for QC methods. Serve as a technical lead for compendial verifications.
• Perform and support QC equipment maintenance and calibration activities in coordination with Facilities, Maintenance, Automation, and external vendors.
• Support the onboarding, qualification, and implementation of new laboratory equipment.
• Review laboratory data and documentation to ensure data integrity, accuracy, and compliance.
• Perform routine laboratory operations, including cleaning, organization, inventory management, reagent preparation, and completion of laboratory logbooks.
• Support reference standards and critical reagents programs, including inventory management and trending activities.
• Complete all required cGMP and job-specific training in a timely manner and assist with training other team members as needed.
• Develop and maintain On-the-Job Training (OJT) materials.
• Author and revise technical documents, including SOPs, work instructions, forms, and laboratory procedures.
• Author and own quality records, including deviations, laboratory investigation reports (LIRs), OOS investigations, and CAPAs.
• Support laboratory inspection readiness and participate in internal and external audits.
• Utilize laboratory systems such as Empower, Sample Manager LIMS, Track Wise, D2, Microsoft Office Suite, Teams, PowerPoint, and Smartsheet.
• Participate in continuous improvement initiatives and cross-functional team meetings.
• Apply scientific thinking and sound judgment to identify issues, communicate solutions, and lead problem resolution efforts.
• Maintain working knowledge of cGMP Quality Control systems and applicable regulatory requirements.

• UHPLC
• qPCR
• SDS-PAGE
• ELISA
• ddPCR
• cGMP
• Quality Control
• Bioanalytical Testing

• UHPLC
• qPCR
• SDS-PAGE
• ELISA

• Bachelor's degree in Molecular Biology, Biology, Analytical Chemistry, Biochemistry, Biotechnology, or a related scientific discipline.
• 1-3+ years of relevant industry experience preferred.

• Experience as a Laboratory Analyst or Scientist performing analytical testing and troubleshooting in a GxP-regulated environment, preferably within Quality Control.
• Hands-on experience with bioanalytical methods and laboratory instrumentation.
• Experience supporting method transfers, technical document authoring, and laboratory investigations.
• Familiarity with cGMP regulations, laboratory safety practices, quality systems, and inspection readiness activities.

• Ability to work safely and effectively in a fast-paced laboratory environment.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Excellent attention to detail and commitment to data integrity.
• Strong verbal and written communication skills.
• Effective problem-solving and troubleshooting abilities.
• Self-motivated, adaptable, and accountable.
• Ability to work independently with minimal supervision while collaborating effectively with cross-functional teams.

• Daily laboratory and computer-based work.
• Frequent use of laboratory PPE and adherence to safety procedures.
• Ability to sit, stand, bend, reach, and perform repetitive hand movements throughout the workday.
• Ability to lift up to 30 pounds, with or without reasonable accommodation.
• Work with biohazardous or infectious materials, chemicals, dry ice, and cleaning agents such as Spor Klenz and bleach.
• Designated as essential personnel and may be…