Objective

• I am seeking a position to expand my experiences in technical quality operation and utilize my chemistry, clinical research, and engineering backgrounds in the discovery and development of future employers.

SUMMARY

• Over 20 years of multiple cross - function experiences in quality control, compliance, and validation expertise in the pharmaceutical and biotechnology industry.
• Skilled in GXP, FDA, ICH, and ISO standards, QC team management, laboratory operations, audits, inspections, and CAPAs.
• A detail-oriented, analytical, and problem-solving leader with a passion for quality excellence and improvement.
• Experience with FDA and IRB procedures and compliance in handling research and ethical issues.
• Documentation through 21 CFR part 11, GCP, and ICH guidelines.
• Experience in reviewing and modifications of existing CRFs, e-CRFs, Protocols, and SOPs
• Validating Computer Systems applications software and hardware with GXP (cGMP, GCP/GLP/GDP)
• Comprehensive working experience with Laboratory equipment research, manufacturing, and documentation.
• Quality-related system compliance activities of Regulatory Risk Assessments (RRA), Regulatory Information Management (RIM), Data Migration Plan & Strategy (DMP & DMS), Requirements Specification (RS (URS/FRS)), Pre/Post Executed Test Scripts, Traceability Matrix, and the overall maintenance of system state of control.
• Experience with electronic document management systems (e.g., QMS, DocIT, and SharePoint); application development and lifecycle management (e.g., HP-ALM and JIRA); and IT service management systems (e.g., ServiceNow, SuccessFactors, and SAP Solution Manager).
• Experience with electronic (QMS) Quality Management Systems, including CTMS, eTMFs, Argus, Documentum, SharePoint, TrackWise, and Veeva Vault systems.
• Reviewing and executing batch records for completeness and compliance with regulatory filings and executing the batch disposition process.
• Experience with MS Office software applications, excellent written and oral communication skills, with strong interpersonal.
• Self-motivated, focused achiever and team player; can work under pressure, leadership qualities; good interfacing with both clients and co-workers.
• Knowledge for the overall strategic development manages in/outsourced resources, evaluates, and selects 3rd party vendors to ensure project objectives are met.
• Efficient operation of LC/MS/MS, HPLC, UPLC, GC - Headspace, TGA, TLC, UV-visible, FTIR, automated/manual dissolution apparatus, and dry/wet chemical techniques.
• Modified test methods to meet development needs under company SOP and ICH guidelines.
• Data acquisition systems include Turbochrom, EZ-Chrom, Totalchrom, Chemstation & Agilent Cerity NDS, Millennium (Empower I/II/III), and Masslynx V 4.1.
• Ensured full compliance with cGMP, GCP, GLP, SOPs, USP/NF, ICH, OSHA, and FDA regulations.
• Support NDA filing processes, working independently in analytical, method development, Validation, and technical support services departments in various manufacturing and analytical environments.
• Reviewed promptly according to company SOP, test results, technical document data in LIMS/ lab notebook, and GMARS.
• Prepared Lab. investigation reports for (OOS) Out of Specification samples and (IND) Investigational of New Drug applications according to SOP and protocol guidelines.

PROFESSIONAL EXPERIENCE

Confidential, Titusville, NJ

Validation Engineer Manager

Responsibilities:

• Create and review SOP, initiate deviation in the QMS, and provide investigations as needed.
• Evaluate the root cause of failures and out-of-specification results and provide and execute corrective and preventive actions.
• Prepare, create, and review validation protocols and execute validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines, analysis of ANDA.
• Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements and prepare final reports;
• Execute post-approval change projects - strategy development, execution plan, data analysis, and work with the Regulatory team for submission,
• Provide training to the new hire and cross-functional departments on the technical part, provide training on the latest protocols and oversee execution, coordinate and communicate all testing with affected functional groups, and evaluates test results.
• Participate and present data in Regulatory Agency, Customer, Corporate, and Internal audits.
• Participate in developments/ improvements to validation programs to remain current with cGMPs and industry standards, participate in deviation investigations to identify root causes via 5 whys analysis, and define corrective and preventative actions (CAPA).
• Maintains effective and cooperative relationships with all departments within and outside the organization.

Confidential, Pennington, NJ

Lead Clinical Quality Control Manager

Responsibilities:

• Worked on two different protocols for oncology and cardiovascular diseases.
• Coordinated and managed activities related to GCP Enterprise Electronic Systems.
• Duties include leading, developing, and maintaining compliance activities across clinical trials regulated GCP environment.
• Reviewed and approved essential clinical study start-up documents, e.g., Clinical protocols, Informed Consent Forms (ICF), Investigator Brochures (IB), Pharmacy Manual, Site Qualification Visit (SVQ), Site Monitoring Visit (SMV), Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), Completion Guidelines, Checklist, Site Activation, and close-out study.
• Participated in study strategy development, documenting 1572 form, PI Financial Discloser From (FDF), Clinical Trial Agreement (CTA), IRB approval letter, PI CV/ML/GCP certificates, and approve documents in eTMF and CTMS systems.
• Managed CRO interactions, including sponsor oversight of operational, functional activities (e.g., study management, monitoring, site management, project master files).
• Created and implements a corrective action plan (CAPA) when performance expectations are not being met.
• Attend cross-functional meetings as needed to represent Clinical Quality Operations and study-specific issues.
• Guided on quality issues that affect the integrity of the data or the system based on FDA ICH guidelines.
• Provided support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training, and others.
• Electronic document management systems (e.g., QMS, DocIT, DocuSign, and SharePoint); application development and lifecycle management (e.g., Client ALM and JIRA); and IT service management systems (e.g., ServiceNow, SuccessFactors, and SAP Solution Manager).

Confidential - New Brunswick, NJ

Quality Assurance & E-Compliance SME Lead

Responsibilities:

• Developed and implements policies and procedures related to Quality related system compliance activities on Regulatory Information Management (RIM), Regulatory Risk Assessments (RRA), Data Migration Plan & Strategy (DMP & DMS), Requirements Specification (RS (URS/FRS)), Pre/Post Executed Test Scripts, Traceability Matrix and the overall maintenance of system state of control.
• Participated in study strategy development, eTMF, CTMS and Summary Report Preparation.
• Created and implements corrective action plans when performance expectations are not being met.
• Attends cross-functional meetings as needed to represent Clinical Operations and study-specific issues.
• Ensured a comprehensive System Development Lifecycle Methodology aligned with GAMP 5 requirements, FDA regulation, and ICH guidelines.
• Guided on quality issues that affect the integrity of the data or the system.
• Provided support services and governance to all supporting IT areas to ensure global alignment to the computer compliance, global validation, and change control standards.
• Provided support to assigned Quality programs, such as Data Integrity Governance, Investigations, and Global Quality Headquarters Training as assigned.
• Electronic document management systems (e.g., QMS, DocIT, and SharePoint); application development and lifecycle management (e.g., Client ALM and JIRA); and IT service management systems (e.g., ServiceNow, SuccessFactors, and SAP Solution Manager).
• Experience with electronic (QMS) Quality Management Systems, including CTMS, eTMFs, Argus, Documentum, SharePoint, TrackWise, and Veeva Vault systems.
• Reviewing and executed batch records for completeness and compliance to regulatory filings and executing the batch disposition process.
• Ensured enterprise-level metrics and tracking for Corporate Computer-related CAPAs are maintained, periodically reviewed, reported appropriately, and recommend corrective actions.
• Approved validated computer system-related change requests.
• Ensured all departments comply with the Company’s policies and procedures, including safety rules and regulations.
• Partnered with the IT Validation team (ITQM) to ensure and oversee risk assessments, ALM test scripts, and incident management align with corporate and data protection standards.

Confidential, East Windsor NJ

Validation Engineer Manager

Responsibilities:

• Wrote SOP, and execute protocols to validate and maintain CAPA’s annual periodic review with FDA regulations.
• Validated Empower software development lifecycle applications (SDLC) based on GXP (cGMP, GCP/GLP) guidelines.
• Managed Change Controls, System Requirements Analyses, and Process Improvement Activities.
• Did project Management and automated mass calibration via IntelliStar Technology, manual quadrupoles’ calibration, MRM sensitivity (ES+/ESI-), maximize/optimize the resolution of quadrupoles mass analyzers (MS1/MS2), sample tuning and full scan, MRM & SIR method development.
• Calibrated, PM, and repair multi-vendor instruments such as LC/MS/MS (Waters Quattro Micro/ ZQ2000/TQD/UPLC/HPLC/GC- Headspace), Agilent 1100/1200/1290 HPLC, Waters HPLC 2695/2790/717 , 600 Delta Prep sys, 2525, 2545, 2676 Fraction Liquid Handler, 2024, 2487, 2489, 2475 FLR, 2998, 2996/996 PDA detectors with minimum supervision.
• Performed IQ, OQ, and PQ for Agilent and Waters systems, complete all documentation with accuracy and compliance with regulatory standards.
• Data acquisition systems configuration such as Mass Lynx, Empower II, III, Totalchrom, and Chemstation.
• Interpreted, optimize & process technical data based on SOP guidelines.
• Provided training to the scientists with course material on LC/MS/MS (Waters TQD/UPLC/HPLC/GC- Headspace).
• Complied with Safety Guidelines to ensure compliance with a GXP according to ICH, and OSHA guidelines.
• Provided remote troubleshooting resolution both on-site and via telephone.
• Demonstrated ownership and manages expenses within company budget and controls inventories.

Confidential, Parsippany, NJ

Process Validation Engineer

Responsibilities:

• Managed technology transfer of manufacturing and testing procedures with GMP subcontractor facilities.
• Provided oversight for manufacturing process development, cGMP manufacturing, and testing of medical device products.
• Developed and qualify analytical methods to support product release, stability testing, immunological and pharmacokinetic testing of non-clinical and clinical samples.
• Developed various applications, including machining and chemical vapor deposition (CVD) reactors.
• Developed, report, and execute CFR 820.75 compliant process validations and identification.
• Wrote and oversee process validation master execution, review and compile resultant data.
• Reviewed project validation studies, statistical process control, perform data analysis and protocol summary reports.
• Provided risk management analysis techniques within a cross-functional team during the review of the finished product.
• Demonstrated ownership, and ability to manage project assignments with a broad scope of complexity, prioritize, and complete work on time.

Confidential, Rahway, NJ

Sr. Services Engineer

Responsibilities:

• Provided IQ, OQ, and PQ after relocation in GXP Lab instruments and follow customer SOP on GC, HPLC, and UPLC systems.
• Calibrated, PM, and repair multi-vendor instruments such as Agilent 1100/1200/1290 HPLC and GC HP 5890/6890, Waters HPLC 2695/2790/717 , 600 Delta Prep sys, 2525, 2545, 2676 Fraction Liquid Handler & 486, 2014, 2487, 2489, 2475 FLR, 2998, 2996/996 PDA detectors with minimum supervision.
• Performed PM and repair of Waters Quattro Micro & ZQ2000 LC/MS hardware, Waters UPLC (classic), (H&I- class) & Nano Acquity, Agilent 6400 ICP-MS, Teledyne Isco Combiflash RF200 & companion and Perkin Elmer GC220 - Headspace TMX.
• Complied with SOPs and Safety Guidelines to ensure compliance with a cGMP, GCP/GLP according to ICH, OSHA, and USP/NF guidelines.
• Interpreted, optimize & process technical data based on protocol guidelines.
• Software instruments configuration experience includes MassLynx, Millennium, Empower I/II, Chemstation, Mass Hunter and Totalchrom.
• Provided diagnostic analysis and problem resolution both on-site and via telephone.
• Maintained expenses within departmental guidelines, and controls inventory, and all company property.

Confidential, Rahway, NJ

Clinical Research Scientist

Responsibilities:

• Performed methods development/transfer and validation based on GXP and ICH guidelines.
• Complied with safety rules, cGMP, GCP & GLP regulations and follow procedures according to EUO, SOPs, ICH, OSHA, and USP/NF guidelines.
• Test API, in-process, and finished product samples by using LC/MS, HPLC, GC, UV visible, FTIR, AAS, KF, TGA automated / manual dissolution apparatus, and wet/chemistry techniques.
• Interpret, optimize & process technical data, and document results in both technical lab notebook & LIMS according to SOP and protocol guidelines.
• Comply with SOPs and Safety Guidelines to ensure compliance with a cGMP, GCP/GLP according to ICH, OSHA, and USP/NF guidelines.
• Updated SOP; write test methods; method validation protocols and reports.
• Data acquisition systems such as Mass Lynx, Millennium, Empower I/II, and Chemsatation Nod configurations.

Confidential, Dayton NJ

Validation Scientist

Responsibilities:

• Validated API in drug substances, in-process and finished product samples using LC/MS, HPLC, GC., FTIR., U.V., AAS, KF., TGA & wet/chemistry techniques to determine assay & impurities.
• Complied with SOPs and Safety Guidelines to ensure compliance with cGMP, GCP/GLP according to ICH, OSHA, and USP/NF guidelines.
• Updated SOP, write test methods, method validation protocols and reports.
• Interpret, optimize & process technical data based on protocol guidelines and document results in a technical lab notebook.
• Experience with instrument software such as Millennium, Empower I/II Chemstation, and TotalChrom.
• Performed validation, calibration, P.M., and repair of laboratory instruments.
• Provided validation engineering such as IQ, OQ, PQ for GC, HPLC, UV, and FTIR
• Provided diagnostic analysis and problem resolution on-site.
• Maintained expenses within departmental guidelines, and controls inventory and all company property.