Raw Materials Quality Control
Resume:
Spina Patel
*** * ****** *** • East Brunswick, NJ 08816 • C: 609-***-****• ***********@*****.***
Professional Profile
Highly focused, detail oriented and results-driven Analytical Chemist with broad experience in performing various analytical testing for finished products, in-process and raw materials. Proficient in performing Method Validation and Stability testing. Demonstrated proficiency with experimental design and skilled at providing in-depth analysis and interpretation of results. Ph.D. in Chemistry (Organic) at Sardar Patel University. Proactive with excellent interpersonal and communication skills. Experience working on multidisciplinary teams and with individuals at all levels from diverse cultural backgrounds.
Core Competencies
• Proficient of leading multifunctional PROJECTS •OOS and OOT investigation• HPLC• GC •ICH guidelines• Scientific & Compliance Principles• Analytical Development & VALIDATION • Leadership •Communication •Team Worker • verbal and written communication •Staff Training & Development Problem Resolution • Laboratory Equipment Operations & Maintenance
Professional Experience
Scientech Laboratories Inc., South Plainfield, NJ 11/2015 - Present
Analytical R&D – Chemist II
As a chemist II; proficient in performing multiple routine testing, handling multiple products, designing several analytical methods based on product and process development. Competent in coordinating complex analytical tasks on process and product testing. Raise issues, develop new ideas to resolve problems and recommend solutions to department and upper level management. Prioritize work in order to increase productivity. Experience in coaching level 1 team members and provide scientific guidance to other departments.
Key Highlights:
Performing analytical chemistry assay based on new existing methodologies, operating analytical instrumentation such as Shimadzu Prominence-I LC-2030C series HPLC (UV, RI detector).
Conduct analytical method development and validation for assay and impurity profile for drug substance and drug products.
Perform stability testing on commercial and noncommercial dermatological products (creams, lotions and ointments), while ensuring compliance with cGMP/GLPs.
Design and initiate Stability protocols as per ICH guidelines, revise methods and procedures in support of stability studies, formulation, method development, and method validation for finished products, drug substances and reference standards.
Experience in handling training and mentoring for core techniques including good documentation, pH, and Balance, Assay, dissolution and water content determination.
Maintaining all kind of documentation as per the FDA requirements. Initiate changes to Quality documents in compliance with cGMP and FDA requirements.
Maintaining the inventory of the controlled drug substances with DEA department and have sound knowledge of DEA regulations.
Troubleshoot all the Analytical Instruments.
Experience in calibration, review and preventive maintenance of critical equipment like HPLC, GC, KF, FTIR, and UV-Vis. Spectrophotometer.
Keep track on qualification of in-house standard as well as USP standards.
Perform laboratories audit regularly in order to maintain compliance and safe work place.
Experience in performing HPLC, GC, Dissolution, and KF titrations for moisture determination etc.
Successfully performed vendor qualification for Pharmaceutical API’s as well as Excipients.
Fast learner with ability to apply knowledge. Multitasking, comfort in building relationship at all levels of the organization. Strong written and verbal communication skills. Able to train new employees on HPLC, GC and Dissolution apparatus. Well Experienced in AR&D and QC department of Pharmaceutical field. Excellent in handling FDA audits and other customer audits.
Competent in statistical in-depth analysis and interpretation of experimental results.
Spina patel
Resume – Page Two • • C: 609-***-****• ***********@*****.***
Professional Synopsis (continued)
Inva-Tech Pharma Solution inc, east Brunswick, NJ 3/2013 - 11/2015
Analytical R&D – Chemist I
Supported running routine testing, method validation and Method transfer from analytical R&D group to QC. Collaborated with Lab scientists and managers to optimize laboratory processes to increase efficiency and effectiveness. Managed lab inventory for new and existing projects and recorded quality control assays data, assay development work in the scientific notebooks for reference purpose with Good Manufacturing Practices. Conducted experiments to support technical troubleshooting and worked with lab team to ensure timely project delivery.
Key Highlights:
Analysis of raw materials, finished products, process validation samples, cleaning validation samples, stability samples.
Checking chemist notebook and prepare the Certificate of Analysis. (COA)
Developing analytical methods for the analysis of active pharmaceutical ingredient (API), drug product and for the cleaning validation and impurities.
Preparation and standardization of volumetric solution, and secondary standard. (In House Standard)
Developing the Residual solvent method for the API.
Maintaining documents for Regulatory Affairs for submission of documents in FDA.
Proficient in calibrating, maintaining and troubleshooting instruments such as HPLC, GC, KF, pH meter, Conductivity meter, Polarimeter, Tap Density meter, Density meter, Particle size analyzer, and Hardness tester, melting point analyzer.
Skilled implementing analytical method transfer for Assay/RS, Dissolution for drug product from research to quality group.
Ability working with timelines and delivering results on time.
Designed, and developed multiple assays for in-process and release testing pursuant to FDA guidelines.
Experience in writing standardized protocols, SOPs, OOS, OOT investigation reports and non-conformances.
Stayed current by attending multiple webinars, seminars and conferences.
Perform full ICH method validation for Assay/RS, Dissolution including Specificity, Linearity, Accuracy, Robustness, Precision and Force degradation studies.
Perform Method verification on USP compendia methods.
Recognized as source of new ideas, innovative solutions and best practices within the Quality role.
Research Student, Sardar Vallabhbhai Patel University 5/2006 -5/2011
Department of Chemistry
Synthesized and characterized organic and polymeric compounds by various analytical techniques like crystallization, distillation, IR, NMR, LC-MS, TGA, DTA, DSC and SEM.
Analyzed various organic and polymeric compounds to determine chemical and physical properties, chemical composition, structure relationships, and reaction utilizing chromatography and spectroscopy techniques.
Monitoring reaction by TLC and compound purified by column chromatography.
Responsible for maintenance and calibration of lab equipment.
Publication: Research Publications:
Synthesis, characterization and dyeing behavior of oligomeric trimethylolmelamine-1- acid azo dyes. Tarulata B. Shah, Spina B Patel, Tushar B Metha, International journal of polymeric materials. 58 12 681-691 September 2009.
Assistant Lecturer NVPAS V.V. Nagar, Gujarat, India. May 2006 - Oct 2006
Prepared and delivered lectures for freshman students on organic chemistry. Assisted students in organic and inorganic qualitative and quantitative analysis during labs.
Education & Certification
Certification:
Bionetwork Capstone Learning Center Wake Technical Community College Raleigh, NC.
Preparation of purification of biological samples for HPLC
Elements of current good manufacturing practices(GMPs)
Good lab practices: FDA and EPA regulations
Risk-Based Approaches to Validation
Validation of control temperature unit (CTUs)
Ph.D. in Organic Chemistry, 2011
Sardar Patel University, India
MS, Analytical Chemistry, 2005
Sardar Patel University, India
BS, Chemistry, 2002
Sardar Patel University, India
REFERENCES:
Available upon request
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