Technically skilled professional with over five years of cGMP and quality systems experience in biotech/pharmaceutical industry. Highly motivated and goal-orientated individual with strong problem solving skills. Demonstrated history of ability to multi-task and adapt to changing priorities. Works well in teams as well as individually. Excellent verbal and written communication skills. Molecular Biology Techniques, Histology Techniques, cGMP Technical Writing (SOP’s), Deviations and CAPAs, Project Management, Advanced Computer Skills, Spreadsheet and Database Creation, GMP Processing/Manufacturing, Work Prioritization, Training/Communication, Compliance, Validation, Track Wise

QC Specialist @ Review of records and documents, for completeness and compliance with QSR and ISO requirements. Review of batch records to support release of raw materials, work in progress and final products. Generation of standard operating procedures to define and improve quality systems functions. In-depth understanding of advanced technical/scientific principles related to the Molecular biology processes. Perform laboratory investigations and product non-conformance investigations followed by writing reports. Support test method Validations for new products. Perform data analysis. Support of agile electronics documentation process as needed. Lead and participate in interdepartmental initiatives for continuous improvements. From May 2013 to Present (2 years 8 months) QA Associate @ Actively participated in ISO audit as QA leader Participated in internal/external audits and regulatory inspections. Performed GMP compliance checks in manufacturing, and logistics. Participated in inspection preparation activities. Performed Supplier qualifications. Coordinated and provided input into the design and presentation of departmental performance metrics. Represented Quality Assurance group in cross-functional meetings, shares subject matter expertise. Facilitate process improvement within other departments, through the use of training, coaching and team participation. Performed Reviews and approval of Major Deviation Investigations and Corrective and Preventative Actions. From September 2013 to April 2014 (8 months) QC Associate @ Excellent hands on tissue fixation and embedding, and sectioning of paraffin embedded tissues using microtome. Performe H&E and various other special IHC stains. Excellent experience in handling and troubleshooting IHC Autostainers like Thermo Scientific Autostainers 360, Dako Autostainers and Montage 360. Performed Stability tests on antibodies, detection systems and ancillary products used for IHC. Performed quality control (QC) testing on antibodies, detection systems, and ancillary products used for immunohistochemistry (IHC). Validation of antibodies using IHC procedures. QC testing of incoming raw material. Generation and reviewing of antibody staining records and SOPs. From March 2011 to May 2013 (2 years 3 months) Intern @ Manufactured different types of media used in microbiological techniques. Manufactured various medias by using Antibiotics. Manufactured buffers, reagents, diluents and acids. From October 2010 to January 2011 (4 months) student @ Cell and Molecular Biology Techniques: Preparing cell lines, isolating cell line, performing PCR on human DNA samples, extraction of DNA from whole blood and buccal smears, Karyotyping, ELISA, Protein and enzymatic assays, Gel Electrophoresis (SDS-PAGE, Agarose), HPLC, media preparation (buffers, culture medium, etc.). Histology and Hematology: Embedding and sectioning of formalin fixed tissues on a microtome for histological analysis. Blood group analysis, preparation of blood smears on slides, complete blood count (CBC), erythrocyte sedimentation count (ESC). Familiar with Immunohistochemistry staining using standardized protocols and autostainers. Familiar with radioactive isotope handling. From January 2010 to January 2011 (1 year 1 month) Sales Executive @ Customer Service Associate and sales executive Worked closely on a daily basis with Accounting Department / Zone Managers/ Sales managers Help Customers on daily basis to solve their problems From May 2007 to April 2009 (2 years) Lecturer @ Designed organized laboratory coursework and delivered lectures in biology, Molecular biology, Biochemistry and Immunology Evaluated students on their performance From August 2002 to January 2006 (3 years 6 months)

Biotech certification, Biochemistry and Molecular Biology @ California State University-East Bay From 2010 to 2010 Master of Science (MSc), Biochemistry and Molecular Biology @ Guru Nanak Dev University From 2000 to 2002 Masters degree, molecular biology and biochemistry @ Ohlone CollegeBachelors degree, Medical science @ Guru Nanak Dev University Harpinderjit Kaur is skilled in: PCR, ELISA, SDS-PAGE, Histology, GMP, Molecular Biology, Lifesciences, Design Control, DNA extraction, RNA isolation, Transfection, Cell Culture, Quality System, ISO 13485, FDA GMP