1. Zoila Miyashiro
304 Morrissee Ave 1st
Fl
Haledon, NJ 07508
Cell: (973) 641-7527
Summary: A professional in the clinical trial packaging Industry with more than 10 years
experience. I also have 3 years in a Dietary Supplement industry.
The following will be the knowledgeable areas I have committed too:
• Production Department
• Distribution Department
• Quality Department
Communicate well with employees, clients, and colleagues. Speak and write English
and Spanish, as well a very good Team Player
• Receiving goods coming into the facility (Bulk product, Components, Labels)
• Incoming material inspection
• In-process inspection and label inspection
• Performing inspections
• Review various types of documentation (pre/post batch records, shipping documentation)
• Batch Record writing according to Purchase Orders or client’s instructions
• Auditing documents
• Writing Change Controls, Client Complaint and Deviations
• Ensure that procedures are being followed in accordance with cGMP’s
Client’s study requirements and SOPs.
• Performing reconciliation on the bulk product, components and labels to ensure is within
acceptable range.
Experience
October 2013-Present Blispak Inc Whippany, NJ
Batch Record writing
• Received & Interpret client’s Purchase Order to start the process.
• Create an In-Process Release Form (Drug description, Lot#, Exp. Date, qty of product to be
produced in blisters, Client’s name and type of Film & Foil to be used, cartooning batch record
and components needed if applicable.
• Order PO (Stamp Proof) as per the purchase order with Lot#, Exp. Date & card size.
• Sent to printing company.
• Printing company will sent back the Stamp Proof for client’s approval.
• Stamp Proof will be sent to client for approval.
• Client approved stamp then it is forwarded to the printing company for them to created the plate
and send it to Blispak for use.
• Approving all type of components for use (IFC’s, Inserts, Trays, Shippers, Film & Foil).
• As well assisting in filing the batch records, components (film, foil, cartons, shippers and zero
out components etc.)
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2. January, 2012- August, 2013 Catalent Pharma (Former Aptuit) Allendale, NJ
Senior Operator/Associate-Packaging (Distribution Coordinator) (Request Processor)
• Verify email confirmation of distribution requests.
• Review and authorize distribution request.
• Assign shipment numbers for manual shipments and maintain logbook.
• Update and maintain the distribution tracking spreadsheet.
May, 2011- January, 2012 Aptuit (Former Almedica) Allendale, NJ
Distribution Operator/Associate Packaging (Documentation Assembler)
• Reviewed the Distribution Activity Summary and Shipping Request.
• Prepared the shipment according to the DAS or MCL.
• Verified the Pick Ticket against the Shipment Request.
• Created the Eve report.
• Created FedEx labels
• Ensured that shipments met timeline due dates.
• Assisted the Order Processor as needed.
• Printed the client provided Request.
• Logged in orders into logbook (If required).
• Picked orders according to the client request in ADMS.
• Entered information in the system(ADMS)
March, 2007- Present Almedica Allendale, NJ
Batch Record Writer- Production Services
• Interpret Packaging Summary and Packaging Request in order to be able to understand the
Specify requirements for each operation.
• Responsible for preparing/writing batch records according to the signed/approved
Client’s Packing Summary and the requested instructions.
• Responsible for making sure that there are sufficient quantity of drug product and components
In the inventory system in order to complete the packaging run.
• Perform verification on the status of the drug product, components, labels and batch Record.
• Responsible for meeting client expectations and timeline due dates.
March, 2003-March, 2007 Almedica Allendale, NJ
Supervisor-Quality Assurance Documentation Batch Record Reviewer
• Responsible for pre and post review of batch records for all packaging operations
(blistering, carding, labeling, teardown, and over-labeling) for clinical trial studies.
• Verify packaging instructions against the signed/approved packaging summary.
• Verify components are in an approved status and all signature requirements are met.
• Verify the post-operation accountability of labels, components and drug products were within
acceptable range.
• Assisted in investigation if accountability is out of acceptable range.
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3. • Generated deviation and change control documentation as required.
• Communicated with client via phone and email regarding batch record questions.
• Generated, reviewed and approved Certificate of Compliance.
• Regularly interacted with other departments and handled issues in a professional manner.
• Independently managed and prioritized duties in order to meet timeline dates.
• Periodically provided SOP and Deviation training to Quality Associates.
December, 2000- March, 2003 Blis-Tech Corporation Fairfield, NJ
Quality Assurance Documentation Specialist
• Responsible for pre-review, packaging operation room close-out and post-review of Batch
Records for all packaging operations (blistering, over-encapsulation, assembly, labeling
for clinical trial studies and commercial packaging.
• Verify that the project management packaging instructions were correct (Clear, legible & approved).
• Verify post-operation accountability of labels, components and drug products are in acceptable range.
• Assisted in investigations when the accountability was out of the acceptable range.
November, 1998- December, 2000 Blis-Tech Corporation Fairfield, NJ
Quality Assurance In-Process Inspector
• Responsible for routinely performing tests on incoming materials for compliance with
clients protocol, FDA regulations and cGMP’s.
• Trained QA Packaging Inspectors on tasks to be performed during packaging operations
as per approved Project Management Packaging Instructions.
• Performed text verifications, weighing and quality determinations.
• Inspected printed materials for variable information and defects.
• Promoted to QA Documentation Specialist in 2000.
November, 1996 – November, 1998 Blis-Tech Corporation Fairfield, NJ
Production Operator
• Machine operator in packing room environment (i.e., over encapsulation, blister forming,
blister sealing, etc).
• Performed carton assembly and labeling operations.
• Promoted to QA In-Process Inspector in 1998.
Education High School- John F. Kennedy HS- Graduate
Computer Programming Institute- Data Entry
Training:
cGMP - Standard Operating Procedures
cGCPs - Standard Operating Procedures
Skills Detail oriented
Simultaneously handle multiple responsibilities
Excellent organizational Skills
Computer skills -Windows, MS Office, Lotus Notes, Excel, Outlook
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4. Fluent in both English and Spanish
References Upon request
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