SAMAYA WYNN
San Leandro, Ca. *****
******.****@*****.***
SUMMARY OF QUALIFICATIONS
Over 4 years of Quality related experience. Skills include: Access, Adobe
Acrobat Professional, Agile, E.T.M.S, Iron Mountain Connect, Lotus Notes,
M.I.T.S, Microsoft Office Suite 2003, PeopleSoft & Power Center
Detailed Knowledge of ISO13485
WORK EXPERIENCE
Abbott Diabetes Care, Alameda, Ca. 5/06 - Present Document Specialist
Document Control 2/2008 - Present Document Specialist
. Maintain 100% accuracy of data reporting by performing frequent
quality checks. Run daily verification reports of all released items
(ACs/DCs/ ECs/ MCs) ensuring all trainable documents such as
procedures, processes, work instructions etc. are accurately entered
and uploaded into the electronic training management system
. Assist with various audits such as FDA, Corporate (AQR), and TUV
(ISO13485) by fulfilling auditor's needs in a timely manner. Serve as
subject matter expert for Internal Audits,
. Create and revise documents as needed to maintain compliance with
regulations.
. Adhere to Corporate retention schedules
. Provide vital records protection services for site-wide Quality
Records such as Lab Notebooks, DHF's, DHR's, DMR's, Transfer of
Authorities, and Training Records to ensure records are safeguarded at
all times.
. Manage pre-archive fire proof room and successfully transferred all
files and records from previous building to new location upon
completion of construction by re-filing and organizing entire room.
Work with various on site departments with assigning locations in room
for record protection and also assist coordinate activities for their
records submission and retrieval.
. Work independently with Legal department and Corporate Records by
retrieving and maintaining confidential and proprietary materials.
. Recognized by management and fellow employees year after year for
being consistent, organized and detailed with willingness to learn and
change as necessary.
. Provide customer service to fellow employees and management by
checking in and out files from various systems. Sending and retrieving
records from off-site storage facilities upon request and as
appropriate.
. Scan and Watermark large amounts of documents
. Issue & retrieve Lab Notebooks along with performing annual Lab
Notebook audits and also tasked with daily general administrative
duties.
Medical Events Group 8/2007 - 2/2008 Complaints Investigation Admin
. Entered and updated case complaints in various Abbott systems.
Maintained daily Medical Device Reporting log, case files and records
on an on going basis. Updated and closed new and existing cases as
needed. Also responsible for mailing files to the FDA daily.
Operations - 7/2006 - 8/2007 Inventory Control Clerk
. Managed warehouse material movement and processed material transfers
. Ran daily reconciliation reports
. Verified and inspected Finished Goods and Issued Quality Control
samples for inspection. Inspected & signed for product shipment.
. Performed daily cycle counts of warehouse inventory along with running
daily spot inspections on inventoried items while investigating any
discrepancies. Processed returned items back in to system, and also
tasked with daily general administrative duties.
Party of America, San Leandro, Ca. 8/05 - 2/06 Administrative Assistant
. Exported daily on-line orders in to the UPS World Ship system. Ran
daily reports of all out going orders along with answering and
directing phone calls. Maintained and updated weekly manifest logs,
. Picked and packed daily out going orders when needed and also checked
and finalized orders for shipments. Palletized and staged orders for
pick-up. Performed cycle counts of warehouse inventory.
GMG Distributors, San Leandro, Ca. 5/03 - 8/05 Operations Assistant
. Scanned, packed, palletized and staged daily out going orders.
Performed monthly physical cycle counts of all inventoried
merchandise. Inspected and stocked received product, processed
returned items back into system.
. Trained and assisted new and fellow employees as needed
A.S.A.P Logistics, Hayward, Ca, 10/02 - 4/03 Administrative Assistant
. Data entry, invoiced purchased orders, ran weekly reports in various
systems, answered and directed calls and perform daily general office
duties
Allegience Health Cardinal, Union City, Ca. 9/01 - 8/02 Material
Handler
. Picked and scanned daily outgoing orders, palletized and staged orders
for delivery. Inspected and labeled received goods
WebVan Bay Area, Oakland, Ca. 11/99 - 7/01 Operations Assistant
. Picked and scanned daily out going orders, performed weekly cycle
counts of inventory, verified expiration dates and inspected for
damaged products. Checked and sorted received goods, replenished and
rotated stock, trained and assisted new and fellow employees
EDUCATION
Castlemont High Oakland, Ca. High School Diploma