Specialist, Quality Control Execution Support (2nd Shift)

Role: Support Analytical Procedure Lifecycle in biopharma QC operations, focusing on method transfer, validation, troubleshooting, and continuous improvement. Responsibilities: oversee new method introduction, evaluate and implement changes to existing methods and equipment, conduct investigations, author technical documentation, and support regulatory audits. Provide technical expertise in separations, biochemistry, and microbiology, with a focus on ensuring GMP compliance and data integrity. Qualifications: Bachelor's or Master's in Chemistry, Biology, or Microbiology; 1+ years in analytical method development, qualification, and transfer within biopharma or pharma. Skills include proficiency with HPLC, ELISA, PCR, microbial, and cell-based assays; strong project and stakeholder management; troubleshooting and risk assessment capabilities; excellent communication; and experience in regulatory interactions. Preferred: familiarity with digital method development and Regulatory submission support. High-Value: biopharmaceutical QC, analytical method lifecycle management, GxP compliance, microbiology, biochemistry, and analytical technology expertise. Work setup: on-site, 2nd shift (evening), with approximately 10% travel.