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Candidate's Name
Street Address  Ashbrook RoadCherry Hill, NJ Street Address
Cell: PHONE NUMBER AVAILABLEEMAIL AVAILABLEA Quality Assurance professional with over 25 years of pharmaceutical industry experience supported by an Electrical Engineering background.PROFESSIONAL EXPERIENCEAurobindo Pharma, Dayton, NJ July, 2019  PresentQuality Assurance SpecialistPerform data/document reviews, investigate/resolve non-conformances, and maintain change control systems.Ensure company adherence to Good Manufacturing Practices (GMPs), Good Documentation Practices, applicable regulatory standards, and internal procedures and practices.Validate products and equipment, follow IQ, OQ, and PQ standards, and calibrate equipment.Produce R&D batches to improve the product quality and perform stability studies for to see the change control effectiveness.Work with other QA functional areas to ensure the deviations, CAPAs, incidents, atypical, out of spec, variants, etc. reports are reviewed and approved as appropriate.In-house auditing, external auditing, and hosting the client auditing, as well as responding to audit comments.Worked within FDA and DEA guidelines.Novavax, Gaithersburg, MD (Remote) February, 2021  December, 2022Batch Record ReviewerPerform data/document reviews, investigate/resolve non-conformances, and maintain change control systems.Review logbooks generated during the manufacture of vaccines for compliance to current Good Manufacturing Practices (cGMP) and Novavax Standard Operating Procedures (SOPs).Communicate and cooperate with cross functional teams and partnered companies to resolve issues on a daily basis.Quotient Sciences, Boothwyn, PA October 16, 2017  June, 2019Senior Quality Assurance SpecialistPerform data/document reviews, investigate/resolve non-conformances, and maintain change control systems.Ensure company adherence to Good Manufacturing Practices (GMPs), Good Documentation Practices, applicable regulatory standards, and internal procedures and practices.Validate products and equipment, follow IQ, OQ, and PQ standards, and calibrate equipment.Produce R&D batches to improve the product quality and perform stability studies for to see the change control effectiveness.Work with other QA functional areas to ensure the deviations, CAPAs, incidents, atypical, out of spec, variants, etc. reports are reviewed and approved as appropriate.In-house auditing, external auditing, and hosting the client auditing, as well as responding to audit comments.Worked within FDA and DEA guidelines.AAA Pharmaceuticals, Lumberton, NJ May 2005  October 15, 2017Senior Quality Assurance SupervisorAssure the quality of raw materials, packaging materials, and labels.Issue batch records.Approve the raw materials, compounding, mixing, compression, and packaging of products.Managed all the packaging lines (bottle line, blister line, carton line)In charge of reviewing and approving all packaged products awaiting distributionReview batch records and final release of shipments.Train all employees to ensure compliance with cGMP and in-house SOPWrite and review SOP, follow up and investigate complaints of any QA related issues.Work with other QA functional areas to ensure the change control, deviations, CAPAs, incidents, atypical, etc. reports are reviewed and approved as appropriate.In-house auditing, third-party auditing, and hosting the client auditing, as well as responding to audit comments.Worked within FDA and DEA guidelines.AAA Pharmaceuticals, Paulsboro, NJ April 2000  May 2005Quality Assurance SupervisorWeigh, check and dispense proper raw materials for the development and validation batches.Conduct batch record review of GMP Batches.Followed up on the batch record corrections to ensure compliance with cGMP.Supervise and approve all stages from raw material receiving up to finished product labeling and consolidation for shipping.Communicate with vendors and suppliers for relevant issues associated with raw materials.Store and quarantine retained sampler in the proper storage room and the update file.Assure all packaging component clearances.Conduct QA in process inspection, audit and line clearance during manufacturing.Worked within FDA and DEA guidelines.Schein Marsam Pharmaceuticals, Cherry Hill, NJ February 1998  April 2000Quality Assurance CoordinatorConcluded batch record documentation reviews.Followed up on the batch record corrections to ensure compliance with quality standards.Supervised finished products consolidation for shipping.Maintained up-date QA electronic database file for product non-conformance reports and atypical events.Checked and sent finished product samples to the chemistry and microbiology lab.Stored the incoming retained sampler in the storage room and the update file.Secured component clearances.Conducted QA in process inspection, audit and line clearance.Maintained autoclave charts and tag review.Worked within FDA and DEA guidelines.Interpharm Inc, Long Island, NY 1990-1993/1994-1998.Quality Assurance Inspector/Supervisor & Lab TechnicianTrained and supervised quality assurance inspectors and organized quality activities in accordance with quality assurance manual.Monitored different areas of manufacturing practices and in-house standard operating procedures.Quarantined, released, and rejected raw materials and packaging material as well as finished products. Sampling Raw material, Packaging materials, and finished products.Monitored and cleared production rooms and packaging lines. Reviewed batch records and conducted internal data integrity audits for both pre and post approval submissions.Monitored and supported the different aspects of the process.Conducted validation and clearing validation programs by collecting samples and testing for physical parameters.Worked within FDA and DEA guidelines.Bangladesh Powerbord, Dhaka 1987-1990Assistant EngineerSupervised maintenance of a 700MW thermal power plant, transmission and distribution high and low voltage equipments, transformer, breaker, isolator, and protective devices.Bangladesh Powerbord, Dhaka 1978-1987Sub-Assistant EngineerEDUCATIONDjambul Engineering Institute, Kazakstan, USSR 1988Bachelors Degree in Electrical EngineeringComilla Polytechnic Institute, Kotbari, Comilla, Bangladesh 1977Electrical Engineering/ DiplomaNKM High School, Comilla, Bangladesh 1974Secondary School CertificateSKILLSProficient in the use of the automatic weight variation equipment disintegration apparatus, moisture analyzer, hardness tester, friabilitor, bulk density tester. Proficient in PC based MS Word and Excel, Dos windows, Database, Internet and Power point.REFERENCESWill be furnished upon request.