OBJECTIVE:

• Seeking a position of responsibility in research and development. To increase knowledge of all fields possible and grow with the Company. Willing and open to learn new procedures according to the work environment and requirement.

PROFESSIONAL EXPERIENCE:

Documentation Specialist

Confidential - Branchburg NJ

Responsibilities:

• Collect and compile donor medical and recoveryrecords.
• Assembled and reviewed and, complete high quality donor medical review files for all donors procured by a specifically assigned group of Tissue Recovery Partners.
• Prioritizes and triages collection of donor information.
• Initial data entry into the Oracle 12 system to the complete review (Level 1 review) analysis of the information to ensure compliance with all applicable state and federal regulations and AATB standards, FDA and state regulations, and in accordance with Confidential ’s LOPs and other requirements.
• Ensure all Level 1 reviews of donor records pertaining to their assignments are accurate and complete before finalizing all transactions in Oracle.
• Act as a contact to Tissue Recovery Partner, to address issues identified by Level 2 or Level 3 reviews and provide follow up and rework to resolve these issues.
• Support all new employees and other departments within Confidential as a technical specialist in donor documentation.
• Identify discrepancies or information gaps present in donor medical charts and retrieves information.
• Prioritize activities to ensure workload is managed to meet department requirements and to meet set department metrics.
• Release/reject the Medical Director reviewed donor charts in the oracle 12 system.

QC Documentation

Confidential -Branchburg NJ

Responsibilities:

• Receipt, inspection and disposition of non-complaint related products returned by clients.
• Oracle transactions for the completion of the FRA returns.
• Communication with Customer Solution, QC Release and Logistics Staff.
• Collecting data to develop metrics surrounding the return process.
• Scrapping the Expired product using Oracle and Track Wise.

QA/QC Documentation Assistant

Confidential - New Brunswick,NJ

Responsibilities:

• Archived all completed Documents for Quality.
• Submitted QA Monthly Report to Head office overseas.
• Collected all Data Required by Auditors during Audits.
• Responsible for Archiving completed Batch Records.
• Maintaining Excel Sheets for supplier information.
• Ordered Supplies for the Quality Assurance & Quality Control Group.
• Updated Excel sheets for CCRs. OOSs and OOTs by extracting information from Track Wise.
• General assistance to QA QC Regulatory Departments.

Documentation specialist -Quality Assurance

Confidential -Cranberry NJ

Responsibilities:

• Assist in writing standard operating procedures (SOPs) that would help define and govern operations in the Oral Care lab. Revising the old SOPs for the Oral Care Department.
• Responsible for the sorting, scanning, organization, cataloguing and creation of electronic copies of various paper files, documents and records pertaining to Arm & Hammer Oral Care Product line.
• Responsible for feeding all the electronic files on the SharePoint site This is a Web site owned by Arm and Hammer that provides a central storage and collaboration space for documents, information, and ideas

Quality Assurance

Confidential - Somerset, NJ

Responsibilities:

• Worked on a project in L’Oreal USA called Project ISIS, a large scale IT transformation program built on SAP system which consisted of spanning all of L’Oreal product formulas.
• Worked and trained on this new standard business software and learned new applications and web technologies.
• Worked with the QA Department to feed all inspection plans for all products currently made in the company on to the SAP.

Technical Services & Support

Confidential - Branchburg, NJ

Responsibilities:

• Processed all material and paperwork according to the area standards and requirements.
• Worked in a GMP Laboratory. Responsible for general upkeep in the lab s and operation and maintenance of lab instruments including Autoclaves and glass washers.
• Analytical laboratory procedures (i.e. formulation, reagent preparation, reading a balance, serial dilutions, pH meter, etc).
• Worked on different database to enter specifications.
• Worked on SAP systems.
• Tracked all document transfers and QA flag details in established spreadsheets using standard business software.
• Kept weekly checks on expired lab ware according to designated expiration dates.
• Processed all Bio-processing, manufacturing and testing records to and from QA on agenda.
• Ensured revision of GMP/SOP documentation as required with subsequent re and communicated the information to department of Learning & Development.
• Generated and processed MDCRs for Technical Support and Service department as needed. Monitored document release notification.
• Contacted document authors as needed to determine requirements for SOPs after the changes.
• Trained to perform Environmental Monitoring for laboratories when required.
• Trained to Prepare Reagents and Formulation of different Buffers.
• Trained to assist in preparation of Investigation Report’s, Change Control Report’s, MCQS’s, QC’s, Card forms etc.
• Trained to perform Cleaning of Radioactive Labs, and perform Swipe Test as required.
• Trained to work in a Clean room environment.
• Responsible to order reagents and chemicals for the lab and responsible to keep the MSDC’s and labels up to date.
• Required to work on the computer at least 40% and always learning new web technology.
• Ran Autoclaves, Depyrogenators, Glass washers; ensured processing of all liquids & lab ware according to GMPs/SOPs.
• Worked with the Validation department to assist them in Validating the Lab Documents and equipments.
• Worked according to SOP’s and other regulations.

Analytical Dept. /Lab. Support

Confidential- Skillman NJ

Responsibilities:

• Ordered items needed by the labs using the Arriba Systems Software. Followed up on order placement by mediating with different suppliers.
• Making sure of placing up to date MSDS’s in the lab. And labeling of all chemicals.
• Ensured maintenance and supplication of various stockrooms and retainer cabinets within the labs. Performed regular lab techniques like evaluation of specific gravity, viscosity, refractive index, ph etc
• Managed discarding of chemical waste and recurrent cleanup of retainer cabinets following the hazard instructions.
• Kept scientific labs equipped with glassware, reagents and other supplies.
• Reading all MSD’s and understanding all control laws, regulations and hazard instructions.

Production/Manufacturing Associate

Confidential - Raritan NJ

Responsibilities:

• Responsible for packaging and reconciliation of paperwork; checked and verified packaged components for shipping of finished products from warehouse.
• Working efficiently to meet deadlines and making sure work was done in an efficient and organized manner.
• Made labels for individual packages following GMPs; palletized finished goods and ensured all batch records are complete.
• Completing all labels for shipping.
• Maintenance of work center as per the GMP rules, generation and filing of SOPs and mandatory professional s such as laboratory safety and shipping regulation.

CAS Department / Account Processor

Confidential - Hopewell, NJ

Responsibilities:

• Processed retirement accounts, IRA, IRRA, ROTH, and SEP. Maintained client database

QA /Data Entry Specialist -Quality Assurance

Confidential - Hopewell, NJ

Responsibilities:

• Quality Assurance Specialist; subordinate to QA manager in identifying and requesting documents from clients.
• Worked on SNAPS computer system to ensure completion and updating of record documents.
• Worked on backfilling and sessions system to update acquired and revised documents.

Assistant Librarian

Confidential - Princeton, NJ

Responsibilities:

• Assisted the librarian in administrative duties.
• Researched for and retrieved the articles of information from scientific journal and magazines.
• Maintained and organized the library floors.