Aradhna Sonik

• Played critical role in new product development projects by providing timely feedback on design parameters from QA/QC perspective.
• Provided expert guidance during regulatory inspections, resulting in positive outcomes for organization.
• Collaborated with cross-functional teams to optimize workflows, resulting in improved productivity.
• Edited, proofed, and critiqued internal documents to improve clarity.
• Ensured compliance with industry standards by staying up-to-date on relevant guidelines, policies, and regulations affecting QC operations.
• Managed successful completion of multiple simultaneous projects while maintaining strict deadlines and high-quality outputs.
• Conducted root cause analyses to identify trends in non-conformance reports, leading to proactive problem-solving strategies.
• Reduced production errors by closely monitoring product specifications and identifying areas for improvement.
• Maintained high levels of data integrity by implementing stringent documentation procedures and training staff on best practices.
• Developed training materials, SOPs, and work instructions to supplement new team member onboarding.
• Enhanced laboratory safety with implementation of proper protocols and regular equipment maintenance.
• Created and revised procedures, checklists and job aids to reduce errors.
• Improved product quality by conducting thorough analyses and implementing corrective actions.
• Monitored KPIs to proactively address bottlenecks and quality issues.
• Organized regular training sessions for team members to enhance their technical knowledge and skills, leading to better performance outcomes.
• Conducted data review and followed standard practices to find solutions.
• Performed routine maintenance and calibration on testing equipment.
• Created testing protocols to be used across product lines.
• Performed tests and inspections to conform to established standards.
• Conducted investigations into questionable test results.
• Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
• Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.

Key Achievements − Key analyst for Method Qualification, executed over 50 assays along with statistical analysis in short period of 10 days, reducing time by half and saving both money and resources by executing experiments with 100% efficiency first time. − Gained in-depth exposure to working of biopharmaceutical Contract manufacturing organization catering to client needs. Responsibilities − Regularly interacted with client to understand their requirements and review progress on development of various methods for quality analysis of drug samples. − Carried out testing for over 200 Drug Substance and Drug Product Samples by Cell based and ELISA Bioassays. − Used various statistical methods such as “F-test” to determine parallelism − Was responsible for maintenance of cell lines, preparation, and characterization of Cell Banks, requiring preparation of 200-300 aliquots per session.
− Extensive analytical experience by qualifying in over 10 GMP test protocols to carry out sample analysis. − Prepared over 50 STPs, SOPs, Specifications, Qualification protocols for equipment at time of Installation, Operation and Performance.

• Managed laboratory resources efficiently, ensuring timely completion of experiments and projects.
• Enhanced overall efficiency within the lab setting through active participation in performance improvement initiatives.
• Maintained accurate records of experiments and results, ensuring reliability and replicability in future studies.
• Enhanced research quality by performing thorough literature reviews and data analysis.
• Worked as member of integrated project team in highly collaborative work environment.
• Learned new laboratory techniques and applied expertise in carrying out enhanced experiments under supervision of senior lab members.
• Molecular analysis of 200 patients via PCR and RT-PCR methods to study the immunological defect occurring in CD4 positive T-regulatory cells in infectious and non-infectious Uveitis.
  Proteomic analysis done via SDS-PAGE on vitreous humour samples as well as lymphocytic proteins for 200 patients. − Flow cytometric analysis using BD LSRFortessa to measure CD4+ cells after separation from blood via centrifugation.

Molecular as well as proteomic analysis involved in study of the cytotoxic effects of fungal secondary metabolites on human cancer cell lines as well as Mycobacterium smegmatis.

-The strongest resumes quantify results. Consider adding numbers to your achievements. E.g., 'Managed approximately 30 incoming calls, emails and faxes per day from customers.'

• Achieved project success by efficiently coordinating resources and managing timelines.
• Implemented streamlined processes for improved team productivity and project outcomes.
• Conducted thorough risk assessments for proactive issue identification and successful resolution of challenges throughout lifecycle of each project.