Quality Assurance Medical

Susan T. Dearing

** ******** ***. *******, *.Y. *4217 716-***-**** 716-***-**** *****.********@*****.***

SUMMARY OF QUALIFICATIONS

Quality Assurance Specialist with extensive experience in a highly regulated industry. With a proven record of quality excellence, I have been recognized with promotions of increasing responsibility. Adept at successful relations with all levels of associates, management, regulatory agencies and customers, working in a team environment.

EMPLOYMENT HISTORY

CPL-Niagara (Formerly Bristol Myers-Squibb Company) Buffalo, N.Y.

2008 to Present: Quality Assurance Specialist

(Company closed 12/2011)

Reviews in-process inspections, weights, torques, etc. results recorded by manufacturing personnel and assures conformance to written procedures and specifications.

Inspects and releases clients finished product samples ensuring they conform to all requirements.

Analyzes, reviews, and approves all bulk manufacturing and packaging lot records for compliance to regulatory specifications, customer requirements, and internal GMP procedures and systems prior to approval.

Complies appropriate lot record documentation and sends copies of completed records to the customer for release of the finished product as required.

Audits manufacturing processes to assure the quality characteristics of each product are appropriately measured and documented.

Issues discrepancy investigations documents and administers the control, approval and tracking of them including maintaining the logs for the investigations and their CAPA.

Facilitates the Annual Product Review Process by establishing a schedule each year for completion, coordinating the assembly of technical documentation and recommendations and preparing summary reports.

Performs destruct audits and inspections as prescribed in AQL audit plans.

Investigates and documents customer complaints.

Writes customer complaint reports.

Participates with customer audits and regulatory audits from agencies such as FDA, EMEA and SHA.

Tracks monthly quality performance measures of quality systems.

Manages change control database.

Knowledgeable in Federal regulations, GMP requirements.

Issue master formula documents for NDA products.

Knowledgeable in lean manufacturing philosophy, continuous improvement (Kaizen, 5S and process mapping).

Proficient in Microsoft Project and Excel.

Approves product for release.

Susan T. Dearing

82 Parkwood Ave. Kenmore, N.Y. 14217 716-***-**** 716-***-**** *****.********@*****.***

2005 to 2008: Senior Records Administrator

Processed and distributed change controls for updating product specifications in the Laboratory Information Management System and test methods.

Responsible for the change control process.

Facilitated change control meetings with team members from various departments.

Issued master formula documents for NDA products.

Maintained master documents and files in the Technical Documentation department.

Update and review site master file as required to ensure appropriate site CAD drawings and schematics and information are included.

Support requests for Regulatory Annual Reports for site NDA products.

Assist in compiling documentation for customer and regulatory site audits.

Assist in compiling documentation requested to support international and domestic regulatory filings.

Participated on a cross functional team to minimize excess cost for raw materials.

1996 to 2005: Complaint Specialist

Processed phone, letter and e-mail inquiries on complaints from customers, pharmacies and physician’s offices.

Completed retain evaluations associated with the complaint.

Performed record review on the documentation associated with the complaint.

Compiled information found from the complaint in report format.

Maintained complaint inquiries in a database for trending purposes.

Issued checks for reimbursement for the complaint.

Organized donations for organizations that inquired about product gifting for fund-raisers.

Susan T. Dearing

82 Parkwood Ave. Kenmore, N.Y. 14217 716-***-**** 716-***-**** *****.********@*****.***

1975 to 2005: Erie County Medical Center Buffalo, N.Y.

Senior Laboratory Technologist-Hematology/Blood Bank

Execute testing analysis on patient blood samples for red cell, white cell and platelet counts.

Performed coagulation testing on patient blood samples.

Carry out cell counts and differential analysis on body fluids.

Performed blood typing and cross matching on patient blood samples.

Carry out quality control testing and calibrations on laboratory instrumentation and equipment.

Teaches medical technology students as part of their education rotation.

Maintained patient data in Hospital database.

Communicated patients’ results to physicians.

EDUCATION

Erie Community College

Degree: A.A.S.

Medical Technology

D’Youville College

Degree: B.S.

Medical Technology

ACCREDITATION

M.L.T. (ASCP) #02578

M.T. (ASCP) #105529

New York State Clinical Laboratory Technologist License

# 011456

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