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Quality Assurance Control/Production Management

Location:
Parlin, NJ
Posted:
February 06, 2024

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Resume:

George Cherian

Piscataway, NJ, ***** +1-732-***-****

ad3evj@r.postjobfree.com

Professional 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.

EXPERIENCE

Director of Quality Sept 2022 - Dec 2023

Maesa, New York, NY

* Oversaw and implemented comprehensive quality management plan.

* Tracked quality improvement implementation process and measured results using KPIs.

* Investigate supplier events to conduct root cause analysis and suggest responsive action to administrators.

* Assess, audit, and monitor the performance of key suppliers to ensure adherence to quality standards.

* Develop, implement, and maintain comprehensive quality assurance programs.

* Analyzed quality control test results and provided feedback and interpretation to production management or staff.

* Collected and analyzed production samples to evaluate quality.

* Monitor customer feedback and work to improve the customer experience by addressing quality issues.

* Establish mechanisms for gathering and acting upon customer insights.

* 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.

* Recruit, develop, and retain top-quality talent within the quality organization. Provide ongoing training and development opportunities for team members.

* Completed various quality audits for different suppliers.

Director of Quality Mar 2018 - Sep 2022

E T Browne Drug Company, East Stroudsburg, PA

* 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 2 managers 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.

* Setup manufacturing and supplier key performance indicators

* Developing and onboarding external manufactures

Sr. Quality Analyst Jan 2013 - Feb 2018

Teva Pharmaceuticals., Parsippany, NJ

* 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.

* 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 system

Quality Engineer (Consultant) Feb 2012 - Oct 2013

Johnson & Johnson, Skillman, NJ

* 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.

Sr. Supply Chain Capabilities Analyst Aug 2006 - Dec 2011

Unilever Americas, Englewood Cliffs, NJ

* 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.

Quality Assurance Manager Apr 1997 - Jan 2006

L'Oréal USA, Piscataway, NJ

* 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 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.

* 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.

* Develop and reviewed SOPs and trained operators and technicians

* Set-up the Plant Compatibility Lab to study the long-term life of the products.

EDUCATION

Master of Science (M.S.) - Industrial Management

New Jersey Institute of Technology, Newark, NJ

Bachelor of Science (B.S.) - Mechanical Engineering

Bangalore University

SKILLS

Quality Assurance, Quality Management, Supplier Audits, Packaging, Raw Materials,, Non-conformances, New products transfer, GMP, Product Inspections

IT/ AUTOMATION

Excel, Word, Access, Outlook, PowerPoint, MS Project, Internet Explorer, SAP, PQMS, EtQ, GSS, TrackWise, Livelink, SharePoint, Compliance Wire



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