Quaility Assurance

QA Documentation Administrator (May ••••• Present)
Manage Document Control and the QA Controlled documents to comply with ••••• CFR Part •••••, •••••, •••••, •••••, •••••, & •••••
Develop, review and edit QA controlled documents including test methods, standard operating procedures and forms.
Maintain, administer and audit product/component specification documentation and applicable drawings.
Initiate, communicate, review and file all external Non-Disclosure Agreements.
Assist in FDA and external customer inspections and document inquiries.
Material Planner and Inventory Reconciliation for Development Materials and Products, including compliance to certificate of compliance or analysis requirements.
Support microbial testing when needed, including aseptic sampling and communicating with external test laboratories.
Daily resolution and communication with project managers and engineering for technical documentation completion.
Perform all product material reviews and required communications with material vendors for compliance to US & EU requirements for GRAS including BPA, melamine and phthalate free documentation.

Watson Laboratories, Inc. Carmel, NY •••••
Quality Assurance Data Auditor (Mar ••••• May •••••)
Maintained all laboratory documentation in compliance with cGMPs and SOPs.
Ensured that logbooks and databases are maintained in a timely manner, verifying the accuracy of the data recorded.
Performed monthly audits: USP, in-house, system suitability standards while maintaining complete documentation.
Audited all controlled substance destruction and inventory reports.
Trained on receiving and dispensing controlled substances.
Ensured that all expired standards are retrieved and disposed of in a timely manner.
Audited all sample kits and completed analytical data packets for completeness and accuracy.
Received analytical test method revisions, retrieves obsolete copies; returns to Documentation Group.
Sent out laboratory samples to contract laboratories for testing.
Reviewed missing or illegible documentation from external sources, necessary for product releases.
Monitored laboratory investigation reports using Track wise and FoxPro.

Laboratory Inventory and Purchasing Coordinator (Mar ••••• Mar •••••)
Tracked inventory levels, prepare purchase requisitions; coordinate delivery schedules with Purchasing.
Coordinated with sales vendors to obtain price quotes, product availability and expedite orders.
Conducted periodic inventory of the lab stockroom; control and monitor usage, and replenished stock.
Received all supplies, columns and standards within the department.

Junior Laboratory Planner (Nov ••••• Mar •••••)
Interfaced with Laboratory Managers, Production and Material Managers to determine laboratory testing priorities for raw materials, in-process materials and finished products.
Scheduled laboratory facilities based on operational priority to maximize use of facilities.
Entered lab samples to be tested; generated weekly schedules based on production needs/lab capacity.
Assigned and closed shop orders using AS•••••

Clerk Typist (Mar ••••• Nov •••••)
Prepare sample kits for testing and analytical reports from laboratory data; maintained departmental files.

EDUCATION

Marist College, Fishkill, NY
Bachelor of Arts in Integrative Studies/Organization, Leadership & Communications (•••••)

Berkeley College, White Plains, NY
Associates in Science in Business Administration & Management (•••••)

TRAINING
Master Control, Salt Lake City, UT
System Administrator Training 2 week course (•••••)

SOFTWARE
Microsoft Office Suite including Access, Visio and Project
Microsoft SharePoint (Intranet design)
Lotus Notes & Microsoft Outlook
FoxPro
AS•••••
Trackwise
MRP
MasterControl
Postgres
LIMS
JD Edwards
SQL Language