Quality Assurance Customer Service
Resume:
Jubin K. Senjalia
Easton, PA 18045
**************@*****.***
QUALIFICATION PROFILE:
A highly skilled and detail-oriented professional with over 5 years of hands-on experience in FDA-regulated industries, specializing in quality assurance, regulatory compliance, and pharmaceutical manufacturing. Adept at managing complex processes and ensuring adherence to cGMP standards, with expertise in change management, deviation investigations, and root cause analysis. Demonstrates strong interpersonal skills, effectively collaborating with cross-functional teams to resolve issues and optimize product quality. Proven track record of managing multiple tasks in fast-paced environments, delegating responsibilities appropriately, and leading teams to achieve operational goals. Experienced in training development, SOP creation, and audit support, with a commitment to continuous process improvement and maintaining high standards of customer service. Holds a Master’s degree in Pharmaceutics and a strong foundation in medicinal chemistry and pharmaceutical sciences. PROFESSIONAL EXPERIENCE:
Sharp Services, Allentown, PA
Senior Specialist, Quality Assurance (Mar 2025 – present) Dept: Bottling/Specialty/Biotech COE
Lead quality assurance efforts for manufacturing and distribution, ensuring compliance with cGMP, FDA, and regulatory standards while reviewing critical documentation.
Manage deviations, conduct root cause analysis, and oversee corrective and preventive actions (CAPAs) to resolve quality issues and prevent recurrence.
Ensure compliance with regulatory standards (FDA, EMA) and support internal and external audits, preparing for inspections and audit responses.
Develop and deliver training programs on quality assurance and GMP compliance, while ensuring SOPs and quality documents are up-to-date and compliant.
Identify risks in processes, collaborate with teams on mitigation strategies, and lead continuous improvement initiatives for operational efficiency.
Oversee supplier qualification and audit vendors to ensure compliance with quality and regulatory standards.
Manage the change control process for equipment, processes, and materials, ensuring minimal impact on product quality and compliance.
Maintain accurate documentation of quality activities and prepare reports on metrics, audit findings, and CAPA effectiveness.
Review and approve product release documentation to ensure all quality and regulatory requirements are met before market release.
Collaborate with cross functional departments to address quality issues and ensure compliance across the production lifecycle.
Lead customer meetings and walk-throughs, addressing concerns in real-time and ensuring alignment on quality expectations.
Provide expert guidance on bottling processes, ensuring compliance and leading efforts for process optimization and best practices.
Lead initiatives to improve manufacturing and packaging processes, driving continuous improvement and addressing inefficiencies.
Make quick decisions to resolve quality issues, ensuring minimal disruption to production and maintaining compliance with regulations.
Stay updated with industry practices, regulatory trends, and attend relevant training to improve quality systems.
Lead or support cross-functional quality projects, ensuring timely completion of tasks and alignment with project goals. Merck, West Point, PA
Specialist, Quality Assurance (Jun 2020 -Sep2022)
Dept: Global Development Quality / Clinical Supplies Quality
Review / Approval / Release / Disposition and Documentation: Involved in the review and approval of executed internal/external packaging, Pre-pack, de-packaging, re-packaging, Clinical Supplies Specification (CSS), Executed Packaging Formal Stability Studies (FSS), Global Clinical Supplies (GCS), Drug Salvage, Packaging Master Data in SAP, Primary Packaging Components, Novel Packaging Components, Blank Label Stock, Printed Label Stock, Re-Evaluation Date Extension (RED), Auxiliary Labels, Additional Country Releases (ACR), Material Transfers (e.g. Inter-site Transfers, Label Release Memos), Compassionate Use / Named Patient Supplies, label stocks before it can be used to package Clinical Finished Good (CFG), Components, Regulatory, Label Stock, Investigator Initiated Supply (IIS), Additional Country (ACR), Compassionate Use, Comparator Releases activities and associated documentation.
Change Management and ERP/SAP System:
Responsible for managing material quality status changes in the ERP/SAP system (On-Hold), and initiating/reviewing/approving change management records.
Quality Regulatory Review and Investigational Medicinal Product (IMP): Ensures that clinical supplies are compliant with regulatory requirements, including review for Investigational Medicinal Product (IMP) certification by external EU Qualified Persons.
Training and SOP Approval:
Develops, approves, and delivers training courses, along with authoring and reviewing standard operating procedures
(SOPs) and GMP lifecycle documents.
Audit Support and Risk Management:
Supports various audits, Quarantine and Recovery activities, walk-throughs, prepares and presents metrics, and assesses risks using Quality Risk Management (QRM) principles.
Deviations / Notice of events (NOE):
Experienced Notice of Event (NOE) or Deviation Originator, Investigator, Reviewer and Approver. Initiated, Implemented, Reviewed and Approved Corrective action Preventive action (CAPA) and Change Control (CC). Sanofi Pasteur, Swiftwater, PA
Principal Investigator (Feb 2016 – Jun 2020)
Dept: Viral/Bacterial Bulk Vaccine Manufacturing
Lead, manage, investigate and write cGMP-compliant deviations for viral and bacterial bulk vaccine manufacturing processes and process support service area.
Work cross-functionally with various support groups and team to identify root cause using various tools and implemented corrective and preventive actions.
Responsible for initiating, managing and implementing change controls and associated CAPAs.
Closely work with Quality Assurance group to coordinate and assist in releasing production batches through resolution of deviations.
Responsible for revising and managing changes to SOPs, SWIs and batch production records to capture changes to manufacturing procedures and processes based on CAPAs.
Initiate, manages and coordinate trainings with production shop-floor team for new and revised procedures and processes.
Liaison between manufacturing and various departments (m-tech, maintenance, engineering, metrology, QA and HSE) to implement changes to improve product processes efficiency and documentation.
Facilitated / coordinated execution of validation and/or maintenance activities in support of operational projects with guidance from both direct Operational Management and Supporting Project Team members.
Developed, revised and communicated departmental metrics regarding safety, quality and productivity.
Occasionally, manage production team to execute day-to-day tasks to meet qualitative production throughputs. Johnson Matthey Pharmaceutical Materials, Inc., Conshohocken, PA Lead Production Technician (Sep 2015 to Jan 2016)
Dept: Controlled Substance Bulk Manufacturing
Manufacturing bulk API products like Opiates, Biopharmaceutical, and other Controlled Substances.
Set-up, operating, completing batch records, maintaining a clean and safe operating area, ensuring batch quality and integrity, troubleshooting problems by process simulation runs, and meeting production schedules in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines.
Exercise scientific/technical knowledge to address process/production deviations to ensure product integrity and to minimize the risk of failures.
Good mechanical aptitude.
Solid understanding of GMP and FDA regulations.
Good understanding of process flows and be able to read and review Process Specific P&IDs.
Ability to independently apply scientific and/or technical knowledge in the performance of job duties. CVS Pharmacy, (Various Locations) NY, NJ
Lead Pharmacy Technician (Jul 2013 to Aug 2015) & (Nov 2006 to Jul 2011) Dept: Pharmacy
Consult with Pharmacist on a daily basis and dispense acute and maintenance prescription drugs to customers
Major tasks like advanced inventory management, pharmacy scheduling, and team building in pharmacy.
Delegation of pharmacy tasks, maximizing service through conflict resolution, effective patient care conversation.
Deliver onsite problem resolutions, answer customer inquiries, and provide unprecedented levels of Pharmacy support
Accurately input and verify prescription entries into RX2000 pharmacy systems and identify corrections or changes in order Reliance Formulation PVT LTD., Vatva- Ahmedabad, India Quality Assurance Officer/ Validation Engineer/ Production Chemist (Jan 2013 to Jun 2013) Dept: Rotational Program
Responsible for monitoring and maintaining quality and compliance of solid and liquid dosage forms.
Provide weekly and monthly reports to senior managers on performance.
Arranging the repair of any QA / related equipment that is malfunctioning.
Ensuring non-conforming products are identified and placed on restriction.
Awareness of regulatory requirement and customer service expectations.
Coordinating the investigation of customer complaints.
Preparing and analyzing information for the purpose of Management Review.
Creating updates and reviewing/approving individual project validation plans and validation deliverables.
Ensuring validation compliance with the company validation master plan and project validation plan.
Reviewing and approving IQ/OQ/PQ procedures and plans.
In process checking of the compression machine in tablet section like weighing, Dissolution Testing (DT), friability, hardness, thickness etc. and reporting to production manager.
Responsible for compliant documentation in, LOG RECORD, TEMP-HUMIDITY RECOED, PREPARING THE MASTER CARD, SOP, Batch Manufacturing Record (BMR), Batch Filling Record (BFR). Express Scripts /Medco, Montvale, NJ
Consultant Analyst (Clinical Benefit Design Testing/Quality Assurance Analyst) (Aug 2011 to Dec 2012) Dept: Business Unit
Provide support to all the client’s lines of business with pre-implementation testing on new clinical configurations.
Develop testing grids for clinical benefit plan configuration testing, and ensure the test scenarios meet client intent.
Leverage various testing platforms and create testing grids to support large scale testing efforts.
Work directly with clinical PES client facing team to understand the clients complex benefit offerings, and ensure all unique benefits are tested.
Establish and maintain clinical benefit configuration testing policies and SOP’s.
Develop strategic relationships/matrix with clinical PES and other members.
Participate in weekly internal client review forum. EDUCATION:
Long Island University - New York
Master of Science in Pharmaceutics – Industrial Pharmacy – May 2015
University at Buffalo, the State University of New York, NY
Bachelor of Science in Medicinal Chemistry – Feb 2012
Bachelor of Arts in Chemistry – Feb 2012
KLE University College of Pharmacy, India
Diploma in Pharmacy – Sep 2006
CORE SKILLS AND COMPETENCIES:
Quality systems (Change Control,
(CAPA)
Process Improvements Change Management
Deviation Investigation Root Cause Analysis Tools Project Management
Quality by Design (QbD) Process Improvements Inventory Management
Regulatory Compliance Problem Solving Lean Six Sigma methodology COMPUTER SKILLS:
MS-Office, TrackWise, Quality eDoc, SAP, ProCal, Labware LIMS, ISOtrain, PI Historion, Master, PharmNet-Web, Phenix, Windows, BCM, Veeva vault, Bluemountain, QAD
HONORS AND AWARDS:
5 Year Certificate of Recognition, CVS Caremark Service Awards (2011)
IEP- Investigator Education Program (Sanofi).
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