technician, quality control, bioassay.

The Role:The individual in this role performs cGMP QC testing and data review for QC Bioassay, release, stability and may support Method Qualification and Acquisition.Here's What You¿ll Do:Supporting method transfers and method developmentPerform tasks as needed to maintain GMP compliancePerforms routine analytical bioassay testing review including, but not limited to Molecular and Cell Biology, including Sequencing, qPCR, and electrophoresis.Review of executed assay packages, in both paper and electronic formats including review of systems data and other analytical outputs.Ensure all laboratory tests are performed correctly and meet cGMP and GDP compliance requirements.Supports special projects assigned.Leads troubleshooting of methods and equipment.Performs data entry and supports trending.Participate in cross functional planning to align QC resources and constraints with business objectives.Stability program supportSupports more junior staff with training and troubleshooting.Author/review/approve SOPs, test methods, QC release documents, instrument qualification documentation, computer system validation documents, training documents and method lifecycle documents as needed.Develop and manage scheduling and status monitoring tools to measure testing capacity, turnaround time, and to communicate progress to the larger organization.Provide guidance and support to the QC-Bioassay team for compliance issues. Support preparation, management, and response to compliance audits.Perform and/or support Certificate of Analysis generation and stability data package as needed.Complete and maintain cGMP documentation for work performed.Lead quality systems records such as investigation, OOS, deviations, change controls, CAPAs as owner.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 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. ...