Sunil Pandey

• Developed and maintained sterilization validation plans; executed studies in compliance with ISO 11135
• Drafted, reviewed, and maintained validation protocols and reports
• Collaborated with cross-functional teams to ensure alignment with regulatory requirements
• Monitored industry regulations, recommended process improvements based on insights
• Investigated sterilization non-conformities; proposed CAPAs
• Conducted training on sterilization validation standards and processes
• Ensured regular calibration and maintenance of sterilization equipment like data loggers programmer(iPBX) and reader (PBC TH-28), Opulus
• Prepared and edited documents to produce precise, accurate and professional communication.
• Input data into spreadsheets and databases.
• Reviewed files, records and other documents to obtain information to respond to requests.
• Kept office supplies well organized and sufficiently stocked, placing orders promptly to replenish materials before depleted.
• Edited and proofread documents for accuracy and completeness.
• Managed daily data entry and kept clerical information accurate and up-to-date.
• Maintained and updated office records, both digital and physical.
• Participated in internal/external audits and responded to regulatory inspections
• Analyzed validation data using statistical techniques to assess process capabilities
• Provided technical support and consultations to clients on sterilization processes.

• Responsible for teaching and instructing students in the microbiology lab (BIO301)
• Proved successful working within tight deadlines and a fast-paced environment.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Identified issues, analyzed information and provided solutions to problems.
• Consistently providing feedback on assignments, lab manual Deliver a range of teaching and assessment activities, including tutorials, aimed at delivering undergraduate-level subjects
• Engaged in professional development and regularly update subject-related knowledge base.
• Checked assignments, proctored tests and provided grades according to university standards.
• Documented attendance and completed assignments to maintain full class and student records.
• Monitored student progress to identify weaknesses and provide recommendations for improvement.

LabExposure

• Experience in Performing media and solution preparation, maintain cell lines,
• Experience in cellular based assays while utilizing aseptic techniques
• Experience in molecular techniques like qPCR, Western blot,
• Experience in PCR, DNA, RNA extraction, Gel Electrophoresis.

• Delivering lectures in the classroom, facilitating discussions, and leading hands-on laboratory activities to support student learning and understanding of biological concepts
• Lab Preparation and Safety: Developing and preparing laboratory activities and materials, ensuring that the laboratory environment is safe and secure, and enforcing laboratory safety protocols and procedures
• Curriculum Development: Developing and updating course materials, syllabi, and assessments to ensure alignment with course goals and objectives
• Collaboration: Collaborating with other faculty members, department chairs, and administrators to ensure a supportive and effective learning environment.
• Used lectures, discussions and demonstrations to increase learning and classroom success.
• Examined and graded assignments and assessments to report grades to personnel.
• Used technological equipment to enhance the process of students' learning.
• Consistently communicated with students to acknowledge and reward positive strides and discuss areas of improvement.
• Impartially evaluated papers, projects and homework assignments of students, delegating grading to teaching assistants when appropriate.
• Taken part in various campus memberships at each assigned school to promote academics and faculty development.

• Consistently provide feedback on assignments, lab manual
• Teach and supervise laboratory exercises associate with topics cover in class
• Support and promote the college and departmental missions centered on excellence in teaching and learning through quality instruction, curriculum enhancement, and service
• Collaborate with department chair, faculty, and peers to evaluate curriculum
• Appropriately document student progress and maintain records including attendance, grading and student learning outcomes.
• Used lectures, discussions and demonstrations to increase learning and classroom success.
• Examined and graded assignments and assessments to report grades to personnel.
• Created and implemented course agendas, lesson plans and activities to successfully meet course objectives.
• Evaluated and supervised student activities and performance levels to provide reports on academic progress.
• Conducted engaging in-class discussions to facilitate learning and encourage participation.
• Graded quizzes, tests, homework, and projects to provide students with timely academic progress information and feedback.

• Responsible for providing knowledgeable representation during laboratory audits and reviewing data procedures, controls, and final reports for completion and accuracy, and monitoring reagents and materials to avoid testing delays
• EO sterilization cycle revision, BI testing after sterilization
• Studying the factors that affect the EO sterilization: Gas, temperature, humidity, and time
• Help in validation and requalification
• bio-burden, support routine quality control testing of medical devices, including bio-burden testing, sterility testing, endotoxin testing, biological indicator testing, enumeration, and environmental monitoring
• Ensured customer complaints are reviewed, evaluated, investigated, documented, and closed in a timely manner to ensure compliance with all applicable global regulatory requirements
• Monitored field quality and analyzed field returns to determine the root cause
• Performed analytical measurements and experiments to qualify or resolve product and process issues
• Participated in Product Review Boards
• Identify non-conformance trends and develop technical investigation plans
• Investigated and analyzed customer/internal complaints
• Generated internal quality documentation such as quality plans, standard operating procedures, and inspection procedures
• Ensured QA, FDA, and ISO compliance.
• Inspected finished goods to verify conformance with customer specifications and company quality standards.
• Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.

• Performed pathogen testing on behalf of both manufacturing industry clients and individual clients, including microbiological tests on raw and finished materials and pathogen testing on E. Coli, P. Aeuroginosa, Salmonella, Listeria, S. Aureus.
• Ensured compliance with EPA and USP in performing and analyzing total plate count, aerobic plate count, anaerobic plate count, combined yeast and mold plate, responsible for PCR, DNA, RNA extraction, Cloning, Gel Electrophoresis
• Interpreted research findings and summarized data into reports.
• Onsite and outside microbiological water testing
• Determining the reason of deviations, nonconformances, OOS, and CAPA investigations.
• Make sure the LIMS records for non-conformances, deviations, customer complaints, OOS, reworks, and CAPAs are accurate.
• Routine examination of batch data, QC findings, and records of environmental monitoring.
• SOP and test method-related document change requests (DCRs) are examined and approved.
• Assist with QA on-the-ground by inspecting the samples that arrived in the lab and QA following the test.
• Take part in internal and external audits, publish reports, and follow up to complete any corrective measures.
• Ordered laboratory equipment and supplies.

• Collected and analyzed biological data about relationships between organisms and their environment; encouraged cooperative management strategies, interpreted research findings, and summarized data into reports
• Worked with several teams on microbiology and biochemistry department research and examined specimens of bodily fluids for microorganisms, as well as analyzed fluid samples to determine how patients are reacting to treatments.
• Assisted with support duties such as filling products, labeling products, testing samples and taking inventory.
• Managed specimen sample handling, receiving, storage and inventory.
• Maintained lab by calibrating equipment and cleaning surfaces and items used.
• Prepared reagents, media and solutions to use for laboratory testing and analysis.
• Assisted scientists by collecting and organizing laboratory data.
• Set and oversaw quality assurance guidelines for laboratory work.