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Manager Quality

Location:
Sutton, MA
Salary:
75K
Posted:
October 15, 2018

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Resume:

Shima G. Shirazi

**B Cold Spring Drive, Sutton, Massachusetts 01590

570-***-**** ac7d24@r.postjobfree.com

Summary

QA Documentation Control Specialist with over seven years’ experience in reviewing, revision control, records and documentation system management. Known for being detail oriented with excellent organizational skills. Ability to be flexible and adaptable to differing work situations. Success in handling multi-task projects in order to meet deadlines and critical day-to-day activities.

Skills

Microsoft Word, Excel, Access, Outlook, Technical Writing, LIMS, Lotus-Notes, MS Project, Qumas EDMS & CATSWEB, Software SAP, ISOxpress

Work Experience

SCHOTT ELECTRONIC PACKAGING, Southbridge, MA January 2017-August 2018

Quality Specialist (QA)

Reviewed and approved product Batch records for release to customers.

Supported Quality Assurance Department requirements where needed following AS9100, ISO-9001, and ISO13485 quality management system.

Reviewed and approved batches to verify product has been produced per plan.

Created all documents for Certificate of Conformances in the part shipping package.

Maintained Calibration system per ISO17025.

Assisted in training of operators on the QMS procedures, Work instructions and submited completed training documents to human resources for filing.

Assisted Quality Assurance manager in preparation of internal, customer and third-party audits and implementation of corrective actions of any findings.

IMMUNOGEN, INC., Norwood, MA October 2011–September 2016

QA Document Management Specialist I

Updated and maintained documents and coordinating Meta data of quality documentation for ImmunoGen sites and applicable CMOs, with a high level of accuracy in QA computer Databases.

Submitted Stability and In-Process TMs to the Share Point, and transferred these documents to the Regulatory Support folders in the system.

Revised and edited SOPs in QUMAS and CATSWEB EDMS as a department Approver.

Adobe Professional and Word advanced experience.

Facilitated the review, issuance and archival of GMP documents, including SOPs, batch records, controlled forms, Assay Sheets, and other supporting documentation.

Maintained Archive Room and provided customer support for archive retrieval. Entered, updated and maintained required data, with a high level of accuracy, in QA computer databases.

Leaded the Archive, Catalogue and supported retention program for GMP documentation in the Site’s Archive Room and supported document storage retrieval from offsite facility – Iron Mountain.

Assigned assay reference numbers to assay datasheets.

Distributed copies of batch production records, supporting documentation, test results, etc. to ImmunoGen partners (Supporting QAO).

Distributed of newly released documents out of EDMS in to their related folders in the Site’s Archive Room.

Performed routine filing of quality Control data and other associated batch record data.

Provided customer support on document change control systems, and located documents both electronically and physically for different departments’ end-users.

BUREAU VERITAS, Taunton, MA April 2011 – September 2011

QA Document Control Coordinator

Executed processes with respect to overall documentation and change control.

Provided support related to document control system requirements and improved overall document functions and change processes.

Managed the quality system requirements as outlined in ISO: 17025 and ISO: 9001 and other such accreditations or certifications.

Provided guidance and document control support to the labs and support services in an accurate and professional manner, while assisting with guidance for the improvement of the quality system.

Ensured the consistency of SOPs, WIN, FRM’s etc. across site through established document control system.

Generated and maintained monthly statistical data compilations, charts, tables, reports and graphs for quality KPI’S.

Maintained local calibration and verification system program, and relationships with calibration suppliers.

Organized, collected and processed information related to various department operational, administrative and technical issues.

Maintained Lotus Notes information catalogues of controlled accesses for databases (GDC, CAR / PAR).

Generated, maintaining Excel spreadsheets, project updates, PowerPoint presentations and Visio flowcharts as necessary.

Facilitated the proper notification of Global CPS DOC’S posted and revised.

Maintained the site notification groups for the LDCP database, tracked training records and followed for changes.

SHIRE PHARMACEUTICAL, INC., Lexington, MA March 2010 – November 2010

QC Sample and Records Coordinator I

Coordinated of clinical and commercial samples (receipt, log-in, aliquoting) between manufacturing facilities to support in-process, lot release, and stability (using LIMS).

Sample shipment/tracking to external contract laboratories for testing.

Maintained training, QC data records/documents, and contract lab reports/results (maintain electronically and file paper records).

Maintained Sample records, Logbooks, Equipment (calibration, schedules), and routine monthly duties.

Set up stability studies and accurately documenting study information.

Created templates and schedules, logged in samples, data entry, created specification, and ran reports.

Communicated and collaborated with QC supervisors and analysts concerning stability workload and schedules.

Scheduled and performed time point sample pulls.

Scheduled and shipped samples to customers or contract laboratories for testing review of assays for cGMP compliance.

Managed, organized, oversee and ensured the objectives of the Quality Control department for timely testing of final formulated Drug products and biologics and stability samples in cGMP environment in line with the Corporate/Site Quality and business goals.

Performed aseptic techniques for handling release and stability samples.

Supported regulatory inspections and internal/external audits.

Education

Associates Degree, Science, Luzerne County Community College, Nanticoke, PA

Certificate, Project Management, University of Phoenix, AZ.

Selected courses from the Bachelor Degree in Management.

Certificate, Technical Writing, University of Maine, Affiliate of University of New Jersey City

Affiliations

Member of Phi Theta Kappa Society

National Dean’s list

College Honor’s list



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