Specialist, Data Reviewer, Quality Control Bioassay

Review executed QC test records for molecular and cell-based assays to ensure accuracy, compliance with Good Documentation Practices (GDPs), and adherence to Data Integrity requirements.,Ensure documentation, data, and records are complete, accurate, and maintained in a state of inspection readiness to support business needs and regulatory audits.,Understand and acquire knowledge to effectively navigate associated laboratory software systems and equipment interfaces, enabling thorough and technically sound record review.,Review reagent and equipment logbooks to verify traceability, compliance, and operational consistency.,Follow all relevant GxP regulations, guidelines, and company policies to ensure full compliance with regulatory and internal requirements.,Execute tasks precisely as defined in internal guiding documents, including but not limited to SOPs and work instructions.,Write and revise SOPs and reports to ensure clarity, technical accuracy, and regulatory alignment.,Support internal and external audits, including audit preparation activities and direct support during inspections.,Assist with troubleshooting issues as applicable to ensure minimal disruption to laboratory operations.,Lead and organize continuous improvement projects to enhance laboratory efficiency, documentation quality, compliance posture, and operational effectiveness.,Work directly with management to ensure QC goals and milestones are met, proactively identifying risks and mitigation strategies.,Perform on the job (OJT) training and act as a mentor to QC Bioassay staff, including mentoring and training junior team members.,Foster a positive and inclusive work culture that promotes collaboration, innovation, accountability, and continuous improvement.,Complete all required training and assigned learning plans according to defined due dates and prescribed requalification cadence.

BA/BS Degree (STEM) with minimum 5 years of experience in a cGMP laboratory, OR Master of Science (STEM) with minimum 3 years of experience in a cGMP laboratory.,Hands-on experience in molecular biology, Cell-based Assays, and Protein Analysis.,Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review.,Working knowledge of USP, ISO, FDA and ICH guidelines (Nice to Have).,Familiarity with laboratory information systems (Nice to Have).,Working knowledge of ALCOA principles (Nice to Have).

Bachelor's Degree or Master's Degree

Maintain audit readiness.