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Click here or scroll down to respond to this candidate Candidate's Name
1 Lexington Drive, Piscataway, NJ Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLEProfessional with over 20 years of experience in Quality Assurance Management. Experience includes audits, internal and external, evaluations as well as nonconformance management and remediation. Established Supplier Relationship Management Program and supplier/third party performance tracking. Prepared project specifications and control procedures. Assisted the manufacturing department in technology transfer to third party manufacturers to ensure quality production and continuous improvement. Established Quality standards and trained personnel. Hired and trained the Quality Control Inspectors. Excellent verbal and written communication skills.
EDUCATION
New Jersey Institute of Technology,
University of BangaloreNewark, NJ 1995India 1986M. S. in Industrial Management
B. S. in Mechanical EngineeringSPECIAL SKILLS
Quality Assurance, Quality Management, Supplier Audits, Packaging, Raw Materials, Non-conformances, New products transfer, GMP, Product InspectionsIT/ AUTOMATIONExcel, Word, Access, Outlook, PowerPoint, MS Project, Internet Explorer, SAP, PQMS, EtQ, GSS, TrackWise, Livelink, SharePoint, Compliance WireWORK EXPERIENCEMaesa, New York, NY 9/2022 12/2023Quality Manager Oversaw and implemented comprehensive quality management plan. Tracked quality improvement implementation process and measured results. Investigate supplier events to conduct root cause analysis and suggest responsive action to administrators. Analyzed quality control test results and provided feedback to leadership. Collected and analyzed production samples to evaluate quality. Supervised and guided inspectors, technicians and other staff. Established product specifications and quality assurance practices. Issued and tracked control documents for various departments and tracked training Implemented a Quality system with policies and procedures. Completed various quality audits for different suppliers to be complaint with ISO protocols Supported, the maintenance and continuously improved the quality at suppliers and third-party sub-contractors. Supported and managed the production operations at contract manufacturers.E T Browne, East Stroudsburg, Pa, 3/2018 9/2022
Quality Manager Trouble shooting manufacturing quality problems and non-conformances and corrective actions. Interacted with vendors in ensuring the quality of components and troubleshoot component defects. Assisted the manufacturing department in technology transfer to ensure quality production and continuous improvement and responsible for the quality systems and product quality for the products produced.
Created procedures and policies to establish month reporting of KPIs to the company s leadership team. Managed the internal audit program. As a director supervised 1 manager and 1 supervisor directly and 35 inspectors indirectly performing Component and Finished Goods inspection and provided mentorship in developing talents.
Developed procedures and policies for the quality department. Reviewed and approved product specifications for manufacture and conducted trainings. Reviewed and approved Batch documentations for FDA regulated products. Document control coordinator for the organization, keeping track of procedures and their lifecycle, issue new procedures and archive old when no longer needed. Installed a QMS system compliant with GMP & GDP, created forms and reports, developed policies and procedures and trained personnel in using the system. Provided training to production and quality personnel in GMP, Hazard material and Safety. Reviewed plant manufacturing procedures and process.Teva, Parsippany, NJ 7/2013-2/2018Sr. Quality Analyst Conducted data validation, test script preparation and testing, security testing and approvals, represented as the Business Process Owner in design and specification development. Coordinated and manage change control program related to GxP computer systems, administer inventory for GxP computer systems. Evaluated Information Technology systems to ensure continued validated status of those. Identified recommendations to ensure quality procedures, programs and policies are consistently followed and met.
Assisted with the collection and prioritization of IT automation requests through the IT/Quality Demand Process.
Under general supervision, managed incidents related to IT systems to ensure investigations are completed and CAPAs are in place. Managed system access and permission to change management systems. Data validation, test script preparation and testing, for corporate computer systemJohnson & Johnson Skillman, NJ 6/2012-3/2013Quality Engineer (Consultant) Performed the First Article Inspections. Identify First Article Inspection failures and communicate to the External Manufacturer. Identified and tabulated customer complaints/returns for detailed investigations. Worked in completing and finalizing Change Control Documentations.Unilever Americas Englewood Cliffs, NJ 4/2006-10/2011Sr. Supply Chain Capabilities Analyst Implemented an approval program for suppliers for the Foods and the Home & Personal Care categories, including packaging and raw materials.
Implemented a program for all the North American plants in supplier relationship management. Including developing new KPIs and measurements. Worked with the programmers to extract and calculate the KPIs and training the plants to perform the calculations. Reviewed audit reports against company requirements to approve suppliers and 3rd party manufacturers. Performed Supplier audits and evaluations of suppliers and 3rd party manufactures. Worked with the suppliers, plant and supply chain to identify and resolve quality and efficiency issues. Assisted the manufacturing plants and the packaging department in resolving the quality issues. Member of a project to implement uniform processes and procedures across the Americas, as a part of the unified SAP implementation.
Prepared specification for the programmers based on requirements from the end-users. Created training materials to train the end-users, created policies and procedures for the new system.L Or al USA Piscataway, NJ 5/1997- 12/2005Quality Assurance Manager Responsible for troubleshooting manufacturing quality problems and non-conformances and corrective actions. Interacted with vendors in ensuring the quality of components and troubleshoot component defects. Assisted the manufacturing department in technology transfer to ensure quality production and continuous improvement.
Conducted validation audits for new and existing sub-contractor, managed projects including launching of new products at co-packers. Conducted the monthly quality meeting with the plants and supplier/third party manufacturers to share KPIs and learnings and resolve quality issues. Created procedures and policies to establish month reporting of KPIs to the company s leadership team. Traveled to external manufacturers to conduct quality audits, training, first productions and trouble shooting. Member of a team that performed new supplier validations and approvals. As a Manager supervised 6 inspectors performing Component and Finished Goods inspection of sub-contracted products.
Trained new hires, and new external party manufactures in the quality system established by the company. Reviewed and approved product specifications for manufacture and conducted trainings. Developed and directed strategic Quality programs that design quality into the manufacturing systems. Reviewed and approved Batch documentations for FDA regulated products. Develop and reviewed SOPs and trained operators and technicians Set-up the Plant Compatibility Lab to study the long-term life of the products.
Reviewed and approved product dispositions |
