Quality Assurance Data Entry
Resume:
NIRANJANA RANA
East Windsor, NJ 08520
EMAIL: - *************@*****.***
Phone # 732-***-****
OBJECTIVE
A Career that allows me to apply my acquired knowledge to its fullest and to further develop my skills.
EDUCATION
Maharaja Sayajirao University of Baroda, India
Master of Commerce in Accounting & Auditing, Banking 1984 Maharaja Sayajirao University of Baroda, India
Bachelor of Commerce in Accounting & Auditing, economics 1982
EXPERIENCE
Berry Global Inc. March-2020- July 2023
Quality Assurance Technician
Monitor and verify products for defects per standard operating procedures and ensure compliance to all GMP, SQF and product safety practices.
Maintain accurate record keeping on all quality reports per standard operating procedures.
Creates and meets all quality goals and KPIs. coordinates, reports, and analyzes quality system processes including but not limited to document control, validations, vendor assessment, corrective action, and nonconformance/deviation control/CAPAs.
Monitor inspection of the packing process.
Perform sampling and testing of products in accordance with quality standards that are traceable to accredited methods.
Know the basic functions and how to operate the following test equipment: Air Gauges, Function Fit Gauges, Plug Gauges, Calipers, Micrometers.
Visual and dimensional inspection of our product during our Injection Molding process to ensure our product is per customer specification using SQF and ISO Guidelines and procedures.
Appco Pharma November-2017-March 2020
Process QA Associate
Issue of inventory cards for incoming materials and affixing of status labels for all the materials.
Collection and maintenance of Incoming materials, in process samples, finished products & stability samples and submission to quality control.
Assigning of batch number for submission batches and commercial batches.
Issue of batch numbers for submission batches and commercial batches.
Equipment Area/room and line clearances for manufacturing/packaging.
In-process quality assurance checks including environmental conditions during manufacturing and packaging.
Requisition and submission of different manufacturing stages of samples to Quality control (incoming materials, in process, finished products, stability samples, others if any).
Monitoring of submission and commercial batches.
Giving the line clearance for usage of equipment’s rooms for manufacturing and packaging.
Collection and maintenance of reserve samples.
Issuing control copies of master documents and logbooks to user departments.
Monitoring of stability chambers.
Maintenance of documentation as needed.
Follow current good manufacturing practices and good documentation practices.
Follow in house safety rules.
Review technical documents like batch records and reports.
Ability to use functional & dimensional test method of capsules & tablets for using caliper, micrometer, hardness, thickness, friability & deviational.
Packaging Coordinator Inc. (PCI) May 2015-November 2017
Quality Assurance Inspector
Responsible for ensuring that Standard Operating Procedures are consistently followed and that cGMP’s are observed, in the course of packaging operations.
Verifying and reconciling materials to and from Clinical Production rooms and works accordingly with Production, Materials Management and Project Management to handle any possible discrepancies.
Inspect and release all clinical packaging rooms to ensure that they have been properly cleaned and that all materials have been removed. Documents all activities accordingly in the associated logbook.
Performing and document hourly QA Inspections on assigned clinical packaging rooms.
Reviewing the batch record and any associated paperwork for any documentation errors made during the clinical packing operation and again when the job is completed prior to submitting the batch record to document control.
Reviewing EMS system printouts for out of specification temperatures, humidity and pressures. Ensuring that all Inventory Management System printed labels are correct against the information provided in the associated protocol.
Performing walk through audits of the production floor, clean storage rooms, warehouse and associated areas to ensure cGMPs are being followed.
Review production logbooks for GMP compliance as each operation is completed and revises SOPs as needed.
Performing additional sampling/testing protocols on clinical trial materials as requested by the customer.
Inspecting and verifying that all clean storage rooms meet approval criteria as per our SOPs.
Participating in customer audits when required.
Ability to communicate with other shift leads to determine workload & needs.
Report & issue or problem with employee or equipment.
Performing other duties or tasks as requested or required by QA Management.
I have experience writing certification of analysis & issue batch records.
Shiseido, East Windsor, NJ February 2010-March 2015
Quality Incoming Inspector
Perform component, in-process and end of line inspections/audits in accordance with SOPs for inspection guidelines. Assure all products meet specifications (aesthetic, fit, form, color, order, appearance) as defined by SOPs, packaging engineering specs, AQL and visual standards. Apply visual and functional test methods as required.
Audit production lines using Inspection Checklist to document and record key product parameters such as batch/lot codes, fill weights, etc.
Perform pallet inspections, which requires lifting and opening of totes (35lbs), packers and folding cartons in accordance with AQL sampling guidelines
Complete required QC inspection records using proper English in clear legible handwriting which conforms to all internal and external (GMP/FDA) requirements
Conduct and evaluate physical inspections utilizing established test methods, comparing results to approved specification, perform dimensional and functional evaluations utilizing caliper, micrometer, Vernier’s, thickness and force gauges. Conduct release torquer and vacuum/leakage test, and fill weight evaluation & ability to read blueprint.
Perform quality status maintenance with MAPICS computer system. Ensure that all inspection, testing and audit documentation are accurate, current and systematically stored. Issue inspection/audit dispositions (accept/reject) and affix appropriate accept/reject stickers on the goods.
Maintaining conformance to established SAI/Customer quality stands, GMP, FDA and OSHA compliance
Perform components and finish good audits to resolve customer and/or production quality issues. Assisting with establishing reworking standard
Completing all the other tasks as directed by the QC-supervisor
Checking area & equipment cleanliness & giving line clearance for packing operation.
Approved the room clearance & equipment clearance based on SOP, GMP, cGMP for complete cleaning or partial cleaning for startup on every new batch.
Check the fill volume, capping, labeling and chip box packing operation.
Maintain the quality level for the packaging line.
Maintain the quality of products based on requirements.
Prepared product labels, Inserts, outsets and master shipper labels as required by the document control and packing lines.
Marinating stability for all the validations products.
Monitoring & co-coordinating all quality assurance activities.
Reconciliation of labels chip boxes & inserts after packing order has been completed & find out final output, the yield, percentage of product.
TECHNICAL SKILLS
Proficient in Microsoft office, COBOL, Computer Programming & Typing.
OTHER SKILLS
Detail ordinated, Multi-tasking
Ability to work as team
Excellent interpersonal and communication skills
Leadership skills
Extremely energetic and organized.
Reference provided upon request.
Contact this candidate