Keith S. McCormick

**** ******* ***** · Niles, ILLinois 60714

Phone: 847-***-**** ada0fz@r.postjobfree.com

PROFESSIONAL SUMMARY

Internal Strategic Partner with Expertise in Quality Assessment/Disposition of Clinical Supplies and Global Supply Chain Management.

Highly accomplished Quality Assurance Professional offering a progressive twenty seven year career with extensive experience partnering with Pharmaceutical Development to drive proactive management of clinical supply coordination and quality disposition of Clinical Supplies. Credited with the agility to address multiple complex issues supporting the global organization while delivering high value integrated processes to ensure business plan execution.

WORK EXPERIENCE

Pfizer (Contract) July 2017 to February 2018

Regulatory Affairs Associate

Transferred documents from Hospira databases to Pfizer databases

Responsible for tracking and completion of assigned registration activities

Assisted in preparation of regulatory strategies and identification of regulatory requirements for submissions

Evaluated manufacturing, labeling and promotional material changes for regulatory impact with guidance

Collaborated to obtain documentation for regulatory purposes

Hospira/Pfizer (Contract) January 2013 to March 2017

Quality Systems Label Editor/Marketing Coordinator

Responsible for compliant Change Control of documentation and labeling

Authority to develop, annotate, format, review and approve documentation and labeling

Released specifications and labeling documentation in accordance with project milestones

Provided daily documentation and labeling support to domestic product development teams

Performed activities related to creation/revision to existing product labeling, manufacturing specifications, test methods, corporate policies and procedures

Abbott Molecular (Contract) March 2010 – October 2012

Quality Professional

Supplier Quality Assurance

Communicated with Suppliers regarding:

-Incoming and in-process product nonconformance’s

-Facilitated supplier interaction and record closure of 220+ nonconformance records to drive resolution with suppliers

-Review, edit and approve nonconformance’s and supplier CAPAs

-Process new and updated material specifications

-Maintain supplier material change notifications and internal processes

-Review/approve packaging inserts/labels

Abbott Laboratories, Abbott Park, IL 2003 - 2009

QA Senior Engineer 1

Performed Quarterly warehouse audits to ensure safety, material location accountability and correct shipment documentation

Reviewed and approved Clinical, Manufacturing and Third Party Manufacturer (Allentown) batch records for packaging operations including: packaging specification, label approval/inspections, line clearances, and finished product inspections

Researched and created spreadsheet of Non-Medical Complaints for FDA external audit to help provide precise, accurate answers in a timely manner

Assisted with the finalization of the Defect Recognition Module for finished clinical supplies to show the different defects that should not pass inspection

Electronically initiated and approved change requests to Global Procedures/Processes

Initiated/Edited/Approved Exception reports including Non-Conformances, Deviations and Potential Non-Conformances

Instructed co-workers on streamlining the process of clinical batch record review from pre-review to final release

GD Searle/Monsanto/Pharmacia/Pfizer, Mt. Prospect, IL 1991 - 2003

QA Specialist/QA Analyst/QC Monitor/QC Technician

Reviewed and approved Clinical Pharmacy, Manufacturing and Third Party Manufacturer (Allentown) batch records for packaging operations including: packaging specification, label approval/inspections, line clearances, and finished product inspections

Assisted in development and maintenance of internal tracking systems to be used as a database for collecting monthly report information and streamlining operations

Performed Internal Audits (i.e, procedures, departments, functions)

Initiated and participated in Incident Investigations and Material Review Boards (MRBs) to ensure documentation is accurate and meets cGMP and regulatory requirements

Assisted in creation and revision of departmental and global SOPS

Interim supervisor role with signature authority in absence of upper management

QA Specialist 2002 2003

QA Analyst 2000 - 2002

QC Monitor 2 1999 - 2000

QC Monitor 1 1998 - 1999

Quality Control Technician III 1994 - 1998

Quality Control Technician II 1991 - 1994

COMPUTER SKILLS

SAP, ePALMs, Pilgrim, Avante, Microsoft Word, Excel, VISIO, Material Tracking System (MTS), SPECDOC (Specifications Document Management System), Electronic Label Approval System (ELAS), Clinicopia, GQMS (Global Quality Management System), QDMS (Quality Document Management System), TRACKWISE, XMS, eDocs, ePas, PEARL, GDMS

EDUCATION

Oakton College - Business

Illinois Certified Pharmacy Technician

License # 049.151233

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