Quality Document Control

BENA SHAH

***********@*****.*** ** Silver Lake Avenue

908-***-**** Edison, NJ 08817

EDUCATION: University of Kota, Kota, India

M.A., Economics July 1988

B.A., Economics & Political Science March 1985

EMPLOYMENT: Cyalume Special Products, Bound Brook, NJ December 2019-prese

Quality Assurance Specialist

Issue Change control and Investigation numbers.

Performs Document Retention Coordinator responsibilities

Performs Stability Program monitor responsibilities

Issue SOP’s and other controlled documents

Track purified water results, enter the data into spreadsheet, file the hard copy

Track employee training records, enter into database, file and making sure for current records

Assist the final drum inspection

Release raw material, review LAR’s and check accuracy and passing results

Issue approval labels and applied on drums

Enter relevant data from batch record into spreadsheet

Assist VP of quality systems with Internal and external Audits

Prepare Annual Product review reports

Compliance Wire experience

Takara Belmont, Somerset, NJ August 2014-November 2019

Quality Assurance Lead/Document specialist

Evaluate personnel requirements of the quality assurance operations department

Responsible for the overall direction, coordination, and evaluation of the unit

Review and release production batch records and products

Review and close out any aborted batch records

Maintain quality metrics for batch record review

Respond to requests from 3rd party customers

Reject any batch that fails to meet specifications

Provide data from batch record review for analysis during annual product reviews

Manage QA auditors in process audits

Provide responses to audit observations and deficiencies

Perform corrective and preventative action (CAPA) for quality issues

Update quality operation departmental training curriculums

Review and update QA departmental SOPS as applicable

Coregistics Packaging, Cranbury, NJ May 2010-July 2014

Quality Assurance Supervisor /IPQA Supervisor

Managed 6 QA inspectors and provided training as needed

Prepared master batch record and batch production record for major clients such as Proctor &Gamble

Performed line inspection for various products and released paperwork for production

Maintained log for retain samples and sent samples back to clients

Performed daily audits for GMP rules of production lines

Generated QA check sheet for clients

Entered data in SAP system

Created non-conformance report for products

Generated GMP labels and verified for production lines

Generated paper work for next day production runs

Attended weekly customer conference calls to identify their needs

Medicia Corporation, Daytona, NJ October 2007-November 2009

Quality Assurance Lead and Document Control Associate

Inspected product components and assured line was ready for production

Provided training to colleagues working on production line

Ensured packaging orders were in accordance with cGMP guidelines

Prepared documents for inspection, filing, SAP system entry, and other documentation tasks

Maintained records and kept track of batch production records

Imclone Systems, Branchburg, NJ October 2005-August 2007

Quality Control /IPQA Assoociate

Inspected incoming raw materials and components for commercial and clinical manufacturing under cGMP guidelines for pharmaceuticals

Conducted aseptic sampling of chemicals in fume hood and class 100 biosafety cabinet located in a class 10,000 clean room

Took samples of gases for qualification and identity testing

Generated and verified labels to identify dispositional material status

Inspected finished product vials to be used in clinical trials

Assisted in the archival process of critical documents

Proofread and approved printed materials for GMP labels & production components

Pharmaceutical Formulations Inc., Edison, NJ March 2000- September 2005

Quality Assurance Inspector

Ensured product was in compliance to current specifications for all packaged products and components

Reviewed packaging orders for compliance to cGMP standards

Performed line inspections utilizing counter machines, leak testers, laser inspectors, weight scales, tablet hardness testers, friabilator, micrometers, and mocon machines

Proofread GMP labels for production lines

Rejected finished products and components that failed to comply with standards

Proofread and approved printed materials for blister packaging production

SKILLS: Microsoft Office (Excel, PowerPoint, Word, Outlook), Great Plans, SAP, Regulatory and FDA audits, Knowledge of cGMP and company SOP guidelines

Project Management training from NJMEP

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