Neera Patel Email & Phone Number

Chesapeake, Va, Us

Virginia, United States

 Development of personnel training program focused on performance improvement Implementation of staff training program Assessment of individual skill set and work performance Oversee training program of ten individuals within the Quality Systems (QS) Post-Production Team Responsible for coordinating, monitoring, and tracking training activities for QS Post-Production Team Execute risk management activities, competency assessments, and training audits Proactive member on multiple Integrated Product Teams (IPTs) to establish new processes and policies Development of Standard Operating Procedures (SOP) Finalize requisite forms needed by effectively capture Objective Quality Evidence (OQE). Development of Memorandum of Agreement (MOA) with Health partners Collaborate with other functional groups to streamline processes related to production, quality, and release ofproducts. Initiate, process, and resolve nonconformance investigations as QS representative Subject matter expert for highly complex cases in multiple product lines such as Musculoskeletal, Skin,Cardiovascular, Placental, and Autograft. Review of batch records and testing documentation for accuracy and completeness Perform product release, tissue movement, and product hold functions in System Applications and Product (SAP)software Apply LEAN process principles to ensure successful project completion in a timely manner with little to no supervision

Virginia, United States

 Manage nine Records Review Coordinator Health Professionals Responsible for Quality Oversight and approval of all Post-Production review and release functions related to graft tissues and medical device grafts In depth knowledge of SAP software, integrating modules such as sales, warehouse, production, cost, and quality controls Instrumental in launch of SAP in 2010 Draft and revise Standard Operating Procedures Signatory authority on all Post-Production Forms and all critical Production Forms reviewed by subordinates Assisted with inputs from the QS Branch during Design Review File processes for all new product launches as required Assisted Information Systems (IS) with SAP testing for the Quality Management module Fostered individual and team development, mentored subordinates on quality and administrative issues Personally led and directed complex, highly political, sensitive, and difficult investigations with both internal and external clients Ensure the execution of corporate goals and objectives Implement of LEAN principles to strengthen and improve process controls related to all record review Ensure that directive, regulation, and upper management direction was properly conveyed to my team and ensured strict adherence through daily interaction and routine meetings Promote a progressive, knowledgeable, and diverse workforce while ensuring fair distribution of work with emphasis of on-time delivery of products Perform performance appraisals for the employees on an annual basis as well as real time feedback through daily interaction Create a positive work environment by being an effective leader and motivator of fellow co-workers Lead the team through numerous successful project completions by exhibiting good virtue, the ability to lead by example, and the establishment of trust with other employees which all resulted in enabling an effective team centered work environment

Virginia, United States

 Provide final review for accuracy and completeness and disposition prior to release for testing and quality control documentation Monitor the status of donor records using both manual and computerized tracking systems and performed review of charts to determine final disposition of all tissues from the donor Work closely with Tissue Operations and Professional Services prioritizing the needed product release to meet the distribution needs Seek assistance from the supervisor to review and evaluate non-conformances and initiated actions to resolve with the affected parties Attend meetings and conferences as required to represent the company as a subject matter expert Coordinate assigned tasks with colleagues and other departments as needed Master the ability to review for accuracy, request corrections, and authorize product release in a timely manner with little to no supervision

Virginia, United States

 Perform and interpret highly complex laboratory testing while adhering to stringent equipment operating specifications Investigate and resolve issues concerning sample integrity, inaccurate or incomplete donor information, and ensured proper identification and documentation of any anomaly in the donor records Receive and process laboratory samples, verified sample transport, collection, labeling, processing, storage, and final preservation parameters Perform quality control testing including testing of reagents, kits, supplies, and media as necessary Interpret microbiological samples and reported test results as a part of the environmental monitoring of the processing facility Document and work with upper management on any corrective actions needed Rotate On-Call duties with other department personnel to address any emergent request in a timely manner

Virginia, United States

 Perform separation, analysis, labeling and Quality Control of Platelet Apheresis products and Leukoreduced Red Blood Cells Responsible for maintenance and monitoring of numerous laboratory equipment Quarantine, label, and release various components of whole blood as required on demand

New Jersey, United States

 Manufacture Elisa Plates and their components (controls: negative, positive and conjugate) from raw materials Master ELISA assay technology and standard principles, theories, and concepts in the field of transfusion medicine Perform specificity testing and accelerated study on HCV, HIV, HBc and HBsAg Work extensively with Hamilton Microlab AT and Ortho Summit Processors Monitor operating specifications for equipment and documented corrective action as needed Design and performed R&D Pilot Studies experiments, analyzed data, drew conclusions, and prepared reports Assist software and system engineers in developing test plans and other technical documents

Associate'S Degree, Clinical/Medical Laboratory Science/Research And Allied Professions

Associate Of Arts And Sciences - Aas, Biology/Biological Sciences, General