Quality Tester Resume
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OBJECTIVE: Seeking a job to utilize my ken in the field of Pharmaceutical Sciences and Clinical Research, and my proficiency in problem solving and analysis.
EDUCATION:
Master’s Degree of Science in Industrial Pharmacy
Bachelor’s Degree of Pharmaceutical Sciences
LAB EXPERIENCE:
- Application of Physical chemistry, Organic chemistry, and material science during formulation development, and during course work and thesis project.
- Familiar with lab techniques: Dissolution, Disintegration, Impurity assay related to Tablets & Capsules, Spectrophotometry.
- Expertise in Chromatography techniques: TLC chromatography, HPLC, GC, FTIR, NMR.
- Excellency in Titrimetric analysis, Extraction, KF, Cleaning techniques, and Assays, Wet Chemistry, Loss on Drying, Calibration of instruments, microscopy, calorimetry.
- Hands on experience on Franz-Chin Diffusion cell, Bath circulator, Double beam spectrophotometer, Hot plate stirrer, Lightnin mixer, Hot air oven, Autoclave, Viscometer, and equipment typically found in formulation labs.
- Lab work experience in formulating Topical products and in-vitro study design of the products and expertise in study data parameters related to topical products.
- Lab working experience in formulation of different cosmetics (skin care, hair care products).
- Experience in formulation of emulsions, suspensions, use of different surfactans, liquid materials.
- Thesis work on Transdermal Drug Delivery Systems and presented seminar on Novel Drug Delivery Systems.
- Batch Production techniques: Mixing, Blending, Drying, Punching, Coating of dosage forms.
- Lab work experience according to cGMP and GLP guidelines.
- Excellent skills in communication, presentation, and event organizing, multi tasking, quick learner.
- Diploma course in Computers: MS-Office (word, power point, excel) & DOS, Internet from S.M.LALL INSTITUTE, Mumbai.
PROFESSIONAL EXPERIENCE:
Confidential,NJ Oct ’11- Present
Quality Assurance
RESPONSIBILITIES- Follow current lab SOPs for testing bulk, raw materials, and finished goods and determine disposition per Reckitt Benckiser Quality procedures
- Review technical documents for ensuring use of current documents - BOMs, Specifications, and Test Methods
- Ensure supplier Certificate of Analysis for raws are received for each shipment, and tests meet with technical raw material specifications requirements
- Prepare Certificates of Analysis for Reckitt Benckiser products when requested by external customers
- Ensure readiness for ISO, Global, and Internal audits
- Operate all lab instrumentation, to include verifications, calibrations, troubleshooting and maintenance
- Provide batch adjustments and corrective actions to Processing in case of failure to meet specifications
- Communicate with Sr. Chemist to update technical specifications as required
- Ensure availability of current bulk and finished goods standards in the QA and Aerosol labs
- Prepare and standardize lab reagents and solutions as needed
- Assist Sr. Chemist with special projects
- Maintain calibration and traceability documentation for externally calibrated instrumentation
- Maintain record retention system for batch production sheets and raw material test results, and Certificates of Analysis for raw material receipts
- Maintain retain retention system for bulk batches and raw materials
- Follow Hazardous Waste, General Waste and Recycled Waste Management and Disposal procedures in lab and adhere to lab safety procedures and Chemical Hygiene Plan
Confidential, NJ May ’10- Sept ‘11
Designation: Scientist I
- Responsibilities include evaluating drug substance, excipients, release and the stability of the product.
- Maintain highest cGMP and SOP standards, and follow FDA regulations & guidelines.
- Performed quantitative analysis of chemical intermediates and drug substances and drug products using USP/NF/EP and in-house test methods like spectrophotometric, wet analysis and dissolutions.
- Performed method validation testing & analysis of pharmaceuticals using instrumental techniques like HPLC, GC, UV and Standard methods.
- Responsible for preformulation activities, assist in scale up and execution of manufacturing sized R & D batches, routine lab work like executing R & D batch, completion of daily lab notebook and following GMP, assist in preparation of submission of document as per guidance by scientist, assist in preparation of documents for ADNA submission.
- Manage all analytical development, qualifications, validations for active pharmaceuticals, excipients, dosage forms, testing, release activities and in-process analytical testing services in support of the formulation development department, development and optimization of new and existing analytical methods for qualification, release testing of products.
Confidential, NJ Oct ’09- April ‘10
Designation: Product Analyst
- Create manual detailing requirements for getting certified as a pharmaceutical distributor in each state.
- Prepare, submit and track licensing applications with relevant paperwork.
- Assist the sales team in targeting the right customers by tracking usage.
- Create reports to help executive team on strategic decisions.
Confidential,Brooklyn Campus, NY Sept ‘07- May ‘09
- Worked as a Graduate Assistant in Pharmaceutical Sciences Dept. under the guidance of Dr.Cutie (division director of dept.)
- Worked as a Graduate Assistant in the Special Education Dept. Job responsibilities include assisting students in the study & performing department’s official work. The skills required are time management, good communication skills as well as interpersonal skills.
- Assisting students in their Pharmaceutical formulation labs, Analytical labs, application of chromatography techniques using HPLC, UV (single beam, double beam), etc.
Confidential,Mumbai, India July ‘06 – Aug ‘07
Designation: Process Associate
- Job profile- Clinical Data Management
- Client- GSK (oncology and respiratory studies)
- Tool: In-Form (Phase Forward)
- Review and understand the study protocol and the timelines.
- Escalate any discrepancy in the clinical data to the DM study manager as appropriate.
- Action study team feedback as required on the data.
- Perform external checks, to handle manual discrepancies and action the same.
- Review the resolved discrepancies and close where appropriate.
- To ensure an error free, quality data with no open queries.
- Attend relevant study teleconference with the GSK staff