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quality assurance specialist resume example with 3+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
  • :
Summary

Seeking a position where I can contribute my organizational and interpersonal skills, knowledge and experience to a company that will give me a challenging opportunity to develop my career. Quality Assurance Specialist with 4 years of experience in Pharmaceutical QA. Sound decision-making and performance analysis talents. Collaborates with groups or work independently with minimal supervision.

Skills
  • Effective communication skills written and verbal.
  • Skilled in Microsoft office programs including word and as well as database programs and general web search.
  • Efficient, resourceful, good leadership qualities and ability to handle multiple tasks.
  • Positive attitude.

Experience
Quality Assurance Specialist , 02/2020 to Current
Acme Smoked FishBrockton, MA,
  • BATCH RECORD REVIWER/DISPOSITION:-
  • Review and approve Executed batch records. Support Product release, including review of validation reports and other supporting documentation to ensure that all information contained within, is correct and accurate.
  • Issued master production and Packing batch record form Master-control system.
  • Checking all material in batch record against with JD Edward, Ensures that any deviations, investigation, Out of Specification (OOS) Report, as they relate to the batch, are identified and addressed in a timely and accurate manner.
  • Accurately calculate expiration dates of CGMP material, assuring that products are not released for human consumption with incorrect or expired dating.
  • Actively support investigation of Batch related deviations and complaints. Ensure all internal and customer timelines are met.
  • Review and approve Master Batch Records and related Minor Document Change Requests. This will involve interaction with internal and external customers to achieve required timelines while maintaining product quality and compliance
  • Review QC Chemistry and Micro Certificates of Analysis for all applicable products manufactured.
  • prepared CoA/CoC for release process, as well releasing all batches in JD Edwards and send release documents to warehouse/supply chain for customer shipments.
  • Perform other assigned duties as well.
QA BATCH RECORD REVIWER , 02/2019 to 01/2020
Acme Smoked FishBrooklyn, NY,
  • Perform batch record review and release in an efficient and timely manner, including double checking calculation to assure that are correct.
  • Review and certify component release documentation and released Raw Material documentation for production use.
  • Review QC Chemistry and Micro Certificates of Analysis for all applicable products manufactured, Review lab data results.
  • Review Analytical Laboratory Report for raw materials, in-process materials, and finished product, ensuring that all
    have been properly signed, verified, and approved, as per SOPs.
  • Ensures that any deviations, investigation, Out of Specification (OOS) Report, as they relate to the batch, are
    identified and addressed in a timely and accurate manner.
  • Accurately calculate expiration dates of CGMP material, assuring that products are not released for human consumption with incorrect or expired dating.
  • Track and evaluate any non-conformances that occur during batch release.
  • Initiates correction of errors and omissions and assists in performing product investigations
  • Review Quality Assurance paperwork for Correctness to be incorporated in the batch record.
  • Working knowledge of database, Spreadsheet application, excel and word processing to perform necessary tasks for preparing required data Analysis
  • Complete and ensure batch record review forms for all observations.
  • Review, complete and maintain a variety of Document required of a CGMP
  • Co-operated with Document Update Retrieval, Scanning and Data entry.
  • Maintained files a Manual Document Control system in Electronic and hard copy.
  • Release all batches in system and inform warehouse for shipment.
Quality Assurance Specialist, 12/2017 to 01/2019
Aurobindo PharmaCity, STATE,
  • In-Process Quality Assurance Responsibilities of In-process during Manufacturing.
  • Perform daily operational check of the USP purified water system and to check of any kind of alarm on the system and record in the alarm Log.
  • Calibrates all tablet weight machine daily, Verify that the daily balance verification of scales and balances in the production area is performed every day..
  • Check the daily balance verification logbook before giving clearance to start the next product.
  • Verify and approve the room and equipment calibrated prior to use.
  • To approve the rerelease of equipment after manufacturing department completes cleaning of PM.
  • Review and approve preventive maintenance or work orders if necessary.
  • Ensure that designated areas clean before that area is used for dispensing, granulation, milling, sifting, blending, compression or coating process.
  • To ensure that when materials of one lot are being transported from processing area to another, there is no cross contamination generated in other processing areas.
  • To approve all dispensing rooms.
  • Give all major and minor clearances for manufacturing rooms prior to start the batch.
  • To collect all composite samples during blend and blend uniformity samples as per the product requirements during blend.
  • To inspect the sample thief and dies prior to use during blend uniformity sampling.
  • To approve the tooling prior to use before major cleaning.
  • Give start up by doing required tests like weight, individual tablet or capsule weight, thickness, hardness, friability and dis integrity to ensure quality standards.
  • Perform all required in-process testing and sampling of manufacturing batches.
  • To perform and collect AQL (Acceptance Quality Level) inspections of the final step of manufacturing of all coated tablets and capsules.
  • Responsible for sampling, AQL testing and approving or rejecting a batch.
  • To dispose any waste produced during in-process testing or incoming sampling of raw materials.
  • To verify the entry of waste in logbook for rejected material and sign in the logbooks.
  • To make all reject labels and apply on the rejected waste prior to dispose.
  • To follow the procedure when submitting samples to quality control for testing by using test request form.
  • To review the test results and release of the equipment.
  • To collect samples as per the protocol for validation batches and submitted to QC.
  • Complete all applicable training forms in a timely manner and forward to document control for archival.
  • Responsibilities of In-Process during Packaging.
  • To approve minor and major cleaning for all packaging rooms prior to start the batch.
  • Verify all materials required for packaging prior to transfer in the room.
  • Approve the packaging labels for lot number and expiry date prior to give start up batch for clear visual verification of batch number and correct expiration date.
Education and Training
Bachelor of Mathematics: , Expected in 03/2014 to MB Claire Science College - ,
GPA:
Dialysis Technician Phlebotomy Technician USA: , Expected in 04/2015 to BN Claire Institute - ,
GPA:
: , Expected in 01/2017 to American Institute of Medical Sciences & Education - Jersey, New
GPA:

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Resume Overview

School Attended

  • MB Claire Science College
  • BN Claire Institute
  • American Institute of Medical Sciences & Education

Job Titles Held:

  • Quality Assurance Specialist
  • QA BATCH RECORD REVIWER
  • Quality Assurance Specialist

Degrees

  • Bachelor of Mathematics
  • Dialysis Technician Phlebotomy Technician USA

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