Quality Control Training

IVETTE GONZALEZ

** ******** ****** *****, ** ****1

Cell#: 973-***-**** E-mail: ********@***.***

SUMMARY OF QUALIFICATIONS

Committed to the highest standards of quality and accuracy

** + years in the pharmaceutical industry Bilingual - Spanish and English

Meet deadlines with minimum supervision Ability to work independently and

multi-task

Excellent communication and organizational skills Highly motivated and team player

Ability to grasp new tasks quickly and efficiently Knowledge of cGMP and FDA

regulations

Experience with MS Word, Excel, Access, PowerPoint Understanding of Safety policies

and procedures

Document Management Systems, SAP, TrackWise Database Administration

File Administration Indexing

EMPLOYMENT HISTORY

LifeCell Corporation, Branchburg, NJ 2013 - Present

Operations Training Administrator

• Responsible for entering training data into TrackWise Training Manager.

• Review executed hard copy training record, insuring they are completed in

compliance with cGMP requirements, and entered into the training database in a

timely manner.

• Maintain hard copy training documentation received from trainers for data entry

in a secure manner, and promptly deliver records to the Training Documentation

group upon completion of data entry activities.

• Utilize TrackWise Learning Manager, develop, maintain, and distribute targeted

reports detailing training status and gaps.

• Provide administrative support for the training team. Develop training event

schedules, reserve rooms and resources, assist in editing of training materials and

presentations.

Halo Pharmaceutical Inc., Whippany, NJ 2008 – 2011

Quality Assurance Associate

• Issued of production documents in which accuracy and attention to detail was

paramount.

• Performed final batch release for drug products in a quick, efficient and compliant

manner.

• Prepared folders for product releases and raw materials.

• Worked with colleagues to improve accuracy of Manufacturing, Packaging, and

Quality Control Batch Records to greater than 99%.

• Managed the systems to confirm, assign, verify production and issue expiration

dates achieved 99% error free, with no stopping of production or recalls.

• Operated database to log process orders, records, SOPs, working copies and

reports.

• Aided in the maintenance of contract manufacturing SOPs, forms, and other

related documents.

• Supported filing, and indexing of all new and revised master batch records.

• Assisted with routing, tracking status, indexing, filing, archiving SOPs and

control documents.

• Updated and maintained spreadsheet with results from Monthly Periodic Review.

• Created, revised, maintained Certificates of Analysis and Certificates of

Compliance templates for all products.

• Developed and distributed Certificate of Analysis, Certificate of Compliance, raw

material, batch results and finished product for manager’s approval.

• Successful trained contract employee to perform batch record issuance and

review.

Abbott Laboratories, Whippany, NJ 2005 – 2008

Quality Control Batch Specialist

• Crossed trained for 6 months as a QC Batch Specialist 3 times a week.

• Follow SOPs and cGMPs maintaining compliance at all times.

• Prepare Manufacturing, Packaging, and QC Batch Records.

• Manage the SAP system to confirm, assign, verify production, and expiration

dates.

• Use Access database to log in process orders, records, working copies and reports.

• Searched and entered issuance information and send control records to

Documentation Center.

• Collaborated with filing and indexing all documentation maintained in the

documentation area ensuring control of documentation.

• Indexed and packaged released folders, batch records, raw materials and lab test

data results to send to off-site storage.

• Update and maintain requirement schedules for packaging.

BASF/Knoll Pharmaceuticals, Abbott Laboratories, Whippany, NJ1997 – 2005

Administrative Specialist II

• Received, monitored and documented Production, Packaging, and Stability

sample movement and results in a highly regulated pharmaceutical environment.

• Managed the issuance, distribution and archiving of laboratory notebooks.

• Utilized TrackWise to enter, maintain, and track training data for the QC Lab and

Stability department in a timely manner.

• Updated QC Lab training matrix and filed training records.

• Distributed reports of training status and gaps to each QC Lab and Stability

personnel to maintain training records in compliance with cGMP requirements.

• Maintained the QC lab training matrix with SOP changes new and obsolete.

• Managed, indexed and filed raw material analytical test reports, validation

protocols and micro lab documentation.

• Placed orders for all QC Lab supplies, equipment and repairs.

• Prepared and shipped samples to an outside analytical company for testing.

• Developed a financial system for the reconciliation of monthly financial reporting

that became a model for the entire site.

• Maintained System Operating Procedures and raw materials Quality Control

reports.

Warner-Lambert Company, Morris Plains, NJ 1991 – 1997

Sr. Administrative Assistant

• Arranged meetings and teleconferences for department.

• Coordinated travel arrangements, trip itineraries, and maintained calendars.

• Used computer software such as Word, Excel, Access and PowerPoint.

• Typed presentations, correspondences for Sales Conferences and National Sales.

• Assisted staff with administrative duties as requested.

• Supported with completion of necessary reports and presentations as requested.

• Utilized high degree of discretion dealing with confidential information.

EDUCATION

Bachelor of Science, Business Administration Centenary College

2007

Associate of Applied Science, Office Systems Technology CC Morris

1992

PROFESSIONAL DEVELOPMENT

Certificate, Customer Service CC Morris 1998

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