Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic
Cammy Balica

Cammy Balica

Flemington,NJ

Summary

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Results-oriented with strong research and decision-making skills to determine specifications and develop action plans. Collaborative with excellent interpersonal and communication skills across diverse groups.

Overview

21
21
years of professional experience
1
1

Pharmaceutical Quality Control Assurance Certification by NJPQCA

Work History

Technical Operations

Scientific Search (Kenvue)
01.2018 - 07.2020
  • Authored and updated product specification
  • Revised manufacturing procedures
  • Authored Change Control, Addendums, protocols, and reports.

Validation Specialist II

Pharma Insight Inc. (Johnson & Johnson Pharma RND)
01.2008 - 09.2015
  • Execution of installation, operational / performance qualifications, deviation investigations/resolutions, review of protocols, change controls, summary reports, retrospective/prospective qualification plans and SOPs
  • Authored, updated, implemented SOPs
  • Performed Quality Risk Assessment
  • Perform temperature mapping studies on refrigerators, freezers, and stability chambers
  • Reviewed Vendor Documents
  • Discussed and Assessed Qualification of Laboratory Instruments based on System Owner testing requirements
  • Maintained and updated the Qualification Traceability Matrix.

Senior Scientist (Test Method Validation)

Roche Molecular Diagnostics
01.2007 - 01.2008
  • Compiled Validation Final Reports
  • Reviewed and drafted comparison reports (i.e
  • Compendial methods versus in house Test Methods)
  • Provided Method Validation gap analysis for chemical and functional test methods
  • Maintained Gap analysis and trending database for the Test Method Validation Department
  • Provided technical assistance to cross functional teams i.e
  • QA, QC, etc.

Senior Scientist (Supervisory Position)

Hoffman-La Roche
01.2002 - 01.2006
  • Participated on various domestic teams as a Quality Control representative to ensure production deadlines are met and to promote quality
  • Interacted with representatives of FDA, DEA and other regulatory agencies as required
  • Conducted/Reviewed Annual Product Review (APR) reports
  • Ensured timely investigation of all compliance issues demonstrated through knowledge of cGMP and provided scientific expertise in leading or directing investigations and reporting results for Quality Assurance review
  • Validated new LIMS system that computerized the current paper sample ownership tracking procedures and labs operation
  • This includes executing validation protocols, writing validation reports, updating over 20 SOP’s, and providing training on the SOP’s
  • Reviewed, evaluated, and approved data generated to ensure sample flow was adequate and data was within normal historical trends
  • (i.e
  • Annual product inspection) Oversee the security and destruction of controlled substances
  • Authored, updated, implemented SOPs, and provided training on SOPs
  • Implemented Trackwise computerized systems for the sample retention area and assisted in the implementation for the stability and standards area
  • Identified training needs and ensured currency of procedures used by personnel
  • Participated in GMP inspections of laboratories in the QC department
  • Acted as backup to Group Leader
  • Ensured adherence to Roche policies and procedures, SOPs, GMPs
  • Established objectives and specific action plan that supports performance metrics.

Senior Chemist

PF Laboratories, Inc.
01.2000 - 01.2002
  • Assure the quality of products manufactured are compliant with current Good Manufacturing Procedures (cGMPs), company SOPs and FDA guidelines
  • Knowledgeable in proper documentation practices according to FDA Regulations in a manufacturing facility Investigate product and test inconsistencies and establish corrective actions to prevent future problems
  • Participated in method validation and Method Transfers
  • Collaborate with various members of management to trouble-shoot, problem solve, and share data to accomplish common goals
  • Application of USP-NF/EP, Instrumentation Procedures and Wet Chemistry Methods to test Raw Materials, In-Process, Intermediates, and Finished Products
  • Instrumentation includes: HPLC (Millennium Software), FT-IR, GC, Dissolution
  • Trained entry-level chemists in laboratory procedures and the importance of proper documentation when reporting data.

Chemist

LNK International
05.2000 - 11.2000
  • Conducted testing on Raw materials, Bulk, and Finished Product Trouble-shoot non-conforming products and followed-up with corrective actions for the release of products

Education

B.S. in Chemistry -

University of Alberta
Alberta, Canada

Skills

  • Microsoft Office (Word, Excel, PowerPoint, Outlook, Skype)
  • Documentum
  • NetReq
  • Guard
  • Trackwise
  • SAP
  • Huddle
  • TRU Vault
  • TRU
  • Teams
  • SharePoint
  • Zoom
  • Data Analysis
  • Technical Troubleshooting
  • Problem Solving
  • Cross-functional Collaboration
  • Risk Assessment
  • Process Improvement
  • Quality Assurance
  • Root Cause Analysis

Certification

  • Pharmaceutical Quality Control Assurance Certification by NJPQCA.
  • Member of the American Chemical Society.

Languages

English
Romanian
French

Timeline

Technical Operations

Scientific Search (Kenvue)
01.2018 - 07.2020

Validation Specialist II

Pharma Insight Inc. (Johnson & Johnson Pharma RND)
01.2008 - 09.2015

Senior Scientist (Test Method Validation)

Roche Molecular Diagnostics
01.2007 - 01.2008

Senior Scientist (Supervisory Position)

Hoffman-La Roche
01.2002 - 01.2006

Chemist

LNK International
05.2000 - 11.2000

Senior Chemist

PF Laboratories, Inc.
01.2000 - 01.2002

B.S. in Chemistry -

University of Alberta

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Cammy Balica