Quality Assurance Medical Device

MIR A. KHAN

E-mail: ***.******@*****.***

SUMMARY: A Quality Assurance Professional with pharmaceutical, Blood

Bank/Stem Cell, and Medical Device industry experience. Proven abilities in

batch record review, Product disposition, manufacturing investigations, SOP

review/issuing, training, and Documentation Control, with the ability to

function in an independent or group environment.

EDUCATION / HONORS:

08/2002 - 05/2007 St. Johns University, College of Pharmacy and Allied

Health, Jamaica, NY

Bachelors Degree in Toxicology / Minor in Chemistry

08/2004 - 05/2005 State University of New York at Rockland, Suffern, NY

Liberal Arts and Sciences

09/2006 - 05/2007 Tau Omega Chi, Toxicology Club, Jamaica, NY

. Assisted in the management and planning of fund-raising projects

. Provided tutorial support to the freshman class regarding Toxicology

and Health Sciences

. Participated in the annual Toxicology Research Presentations and group

discussion with faculty and students

EXPERIENCE:

Sekisui Diagnostics, LLC, Stamford Ct. 01/2011 - Present

Quality Assurance Specialist

. Maintain, monitor and ensure compliance to the quality and

documentation systems

. Review production records (Batch Records) and approve product releases

. Carry out internal audits (GMP environment) - Assist in external

audits (FDA, ISO)

. Prepare monthly reports on batch record metrics and summaries on

nonconformities (NCR's)

. Facilitate changes to SOP's, policies, training materials, and forms

via the change review system

. Support product quality / co-manufacturing failure investigation

. Ensure laboratory equipment is up to date in regards to preventive

maintenance and calibration

. Update Supplier Files on a yearly basis (Supplier Quality

Questionnaires)

. Assist Regulatory Director (off-site) with any regulatory requests and

actions for Stamford site. (Tech File updates, 510K, Recall

Documentation Coordinator)

Community Blood Services, Paramus NJ 12/2009 -

12/2010

Quality Assurance Specialist

. Responsible for the logging and tracking of ongoing and submitted

documents [Standard operating procedures (SOPs), procedural forms,

incident/accident reports, validation reports, product recalls,

audits]

. Responsible for the maintenance of QA controlled documents: Provided

copies of requested executed documents or reports for departments as

required or requested; Oversaw and coordinated the review and revision

of documents, procedures and forms issued via Share Point software;

established and maintained an archiving process and procedures for

obsolete records and documents

. Maintained Microsoft Windows Share Point software, and controlled

access to system

. Assisted with the creation of Documentation Control Standard Operating

Procedures

. Assisted with scheduling internal Focus and Process Audits

. Assisted with review and revision of QA SOPs, attachments, and forms

for compliance with internal and external format requirements and

policies, and performed SOP validations

. Played an active role in conducting and maintaining the QA Committee

. Attended and actively participated in continuing education activities

relating to Quality Assurance (AABB teleconferences, e-learning,

seminars, and workshops)

. Played an active role in external audits/inspections conducted by

Regulatory and Accrediting agencies

. Performed scheduled review of ISENSIX (ARMS) departmental reports

(Temp. monitoring)

. Created monthly metric reports for the Standard Operating Procedures

Issued, Revised, and Retired

Wyeth Pharmaceuticals, Pearl River, NY 07/2007

- 02/2009 Quality Assurance Specialist III - Contract

03/2008 - 02/2009

. QA Specialist in Formulations Dept. for Vaccine Production

. Reviewed batch records (MBRs, PBRs) and gave disposition (approval,

rejection, etc.) to the lot or material produced to ensure that all

steps had been performed and verified where applicable, and that all

limits and specifications had been met and the raw materials and

solutions had been tested and released. (GMP environment and ensured

Good Documentation Practices were followed)

. Identified basic technical problems and developed problem-solving

skills in consultation with supervisors and managers

. Analyzed and interpreted study results, investigations, etc. in

consultation with the supervisor

. Initiated investigations (MIR, LIR) for any findings that may have

required additional information and needed to determine if there was

any impact on product

. Trained on related SOPs and computer-based programs. (LIMS, SAP, EDMS,

GXPHARMA, TRACKWISE)

. Participated in daily departmental meetings with QA department and

production department

. Trained newly hired QA associates on Batch Record Review and

Disposition activities

. Daily contact with Production team, QC Labs, and Operational Resource

Management Team

. Responsible for updating and maintaining monthly metrics for Raw

Materials

Archivist/Associate Scientist - Contract 07/2007

- 03/2008

Archived study files from activities conducted within the Bioanalytical R&D

Division

. Interacted with study directors to ensure that all aspects of study

conduct were included in these files

. Developed a good understanding of working in a GLP environment and

become familiar with all relevant SOPs

. Assisted SMART (Study Management and Resource Tracking) manager is

Data Management for drug safety department.

. Issued new study protocol numbers and updated study information in

SMART

Walgreens Pharmacy, New City, NY 10/2004 -

07/2007

Pharmacy Technician

. Ensured each prescription was filled properly and guaranteed timely

service for each patient

. Registered new patient information into the Walgreens national system,

while following HIPAA regulations

. Oversaw day to day operations and weekly warehouse orders of medicine

and pharmacy products

. Answered OTC items/ Prescription Item questions with the best of my

knowledge

. Helped patients decide which OTC item was most suitable for each of

their specific symptoms

. When needed, got in contact with physicians, nurses and physician's

assistants, to verify directions, doses, and drug dispensing for

prescriptions, as well as insurance issues, such as Prior

Authorizations due to each insurance company's Formulary

. Assisted with training of newly hired employees, going over technician

responsibilities, duties, while following HIPAA regulations

CERTIFICATIONS:

. ASQ (American Society of Quality) - CQIA - Certified Quality

Improvement Associate

TECHNICAL EXPERIENCE:

Laboratory Instruments (Classroom Setting Only): Centrifuges, Electronic

Pipette, GC/MS, HPLC, Cell Culture, Gross Screening with mice and proper

animal handling techniques, SYRINGE-IP, SC,IM, and IV injections of various

drugs.

Applications: MS Office Suite/ Excel/ Access/ Power Point/ Word/

Outlook/LIMS

/SAP/GXPHARMA/EDMS/Trackwise, Adobe, Microsoft Share Point.

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