Quality Manager

Karen L. Pittman

Phone: 817-***-****

*****.**********@*****.***

Quality Assurance Professional with 25 years of increasing responsibilities within the pharmaceutical industry; including 12 years in leadership roles. Experienced in: Parenterals manufacturing, Medical Device manufacturing, NCR investigations, CAPA, lean manufacturing, six sigma, DMAIC approach, Kepner-Tregoe Root Cause Analysis, Quality Metrics tracking, internal and external audit support, validation, change control, TrackWise, CATSWeb, Word, Excel, Access, Visio, SAP, and other inventory management systems. Working knowledge of regulatory requirements such as cGMP, FDA CFR 21 and guidelines, ISO, and the European Medicines Guidelines.

QUALITY SYSTEMS MANAGER

Fresenius Medical Care – North America, Irving, TX – 4/2015 to 4/2016

Manage the Quality Systems Groups: Laboratory, Incoming Inspection and Release, Lot Release, Validations, Calibrations, Line Release, Complaint Investigations, Non-Conformance Investigations (NCR), CAPA Investigations, Laboratory Investigations, Supplier Investigations, Document Control, Change Control, Audits, and Tracking and Trending of Quality Metrics for Management Review

Assigned as Management Representative for the facility. Coordinate and manage all facility audits, including corporate, internal and regulatory audits. Chair site Material Review Board, CAPA Review Board and Validation Review Board. Review/Approve all validation protocols, NCR, CAPA Investigations, Laboratory Investigations, Facility Change Requests, and Monthly Training Effectiveness Audits.

Manage a staff of 5 direct reports and 17 indirect reports. Direct reports: Laboratory Supervisor, Supervisor Inspection, Quality Systems Supervisor, Quality Engineer, CAPA Engineer, and Validation Engineer.

Responsible for interviewing, selecting, and training personnel. Evaluate personnel performance and recommend developmental activities (recommend merit increases based on annual performance review).

QUALITY ASSURANCE MANAGER, OPERATIONS

Alcon Research, Ltd., Fort Worth, TX – 4/2012 to 5/2014

Manage QA review/approvals of validation protocols and technical reports. Managed a staff of three Senior QA Compliance Associates in the process of reviewing/approving change requests, and multiple validation projects for new process lines.

Manage batch release and document control processes. Managed a group of one QA Supervisor with 5 QA associates in the processes of document change control and batch release.

Responsible for NCR review/approval, including CAPA. Utilize DMAIC approach and other investigational tools to drive investigations to root cause and identify appropriate CAPA.

Provide support for regulatory and internal audits as necessary.

MANAGER II QA

Baxter Pharmaceutical Solutions, LLC, Bloomington, IN – 1/2010 to 3/2012

Maintain Quality oversight for Building D manufacturing operations. Ensure compliance to all standard operating procedures, corporate quality policies, and Federal and European regulations and guidance. Represent Filling Quality during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs

Facilitate an environment of teamwork and communication between Quality Assurance, Production, and other support functions as necessary to meet plant and department goals/objectives. Communicate effectively with production team members, multiple levels of management, and other customer support departments.

Provide leadership and direction for Filling Quality Line Operations and Batch Release. Ensure Quality review of batch records in order to achieve internal targets and contractual commitments for batch release. Ensure training compliance for QA Line Operations and Batch release.

Interview, hire, coach, and develop staff. Conduct annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.

Lead and participate in teams for continuous improvement project activities. Support lean initiatives, and participate in Kaizen events.

Participate in escalated client issue resolutions. Provide quality guidance and recommendations during conference calls, client visits, and audits.

Review and Approve Failure Investigation Reports for deviations and or non-compliance issues that occur during production activities and ensures thorough investigation, root cause analysis, and corrective and preventative action

Developed and presented a training course on how to conduct investigations. Includes discussions on investigation and interview techniques, root cause analysis tools, DMAIC approach, corrective/preventive action, product disposition, and technical report writing

MANAGER, QA

Enzon Pharmaceuticals, Inc., Indianapolis, IN – 7/2004 to 10/2009

Manage the QAPR and QAIPC Staffs of Compliance Associates and QA Inspectors. Hire, train new employees. Complete performance reviews. Provide reward / disciplinary action as needed. Develop individual incentive goals and employee development plans. Address complaints and resolve problems. Coordinate workload for both QAIPC and QAPR. Maintain departmental communications.

Perform QA management responsibilities. Develop departmental goals and objectives, ensuring they support company goals and objectives. Assist in development of departmental budgets. Participate in the forecasting process, and assess headcount requirements. Review/approve MCCF (Modification Change Control Forms), Validation Protocols, IT Change Notices and deviations.

Maintain Quality oversight of all manufacturing operations. Elevate issues to senior management as appropriate. Ensure that In-Process Control and Product Release quality assurance systems comply with domestic and international cGMPs, regulatory, and industry standards. Represent areas of responsibility during regulatory inspections. Develop and improve Quality Systems, programs, and procedures to promote, facilitate, and ensure compliance.

Coordinate the release of all raw materials and finished packaged product. Manage batch and test record review. Ensure product complies with standards and specifications. Establish and maintain quality systems relating to record review and release. Manage the review of incoming test data and subsequent approval or rejection of raw materials. Approve Artwork for packaging/labeling components. Maintain the inspection and storage of raw material retention samples.

Supported plant consolidation efforts. Ensured QA support in project activities to transfer the manufacturing, filling, inspection, and packaging processes for Oncaspar and Adagen products from Enzon, NJ to Enzon, IN manufacturing facility.

Participate in and provide QA support for various projects. Includes: addition of new CMO products, Clinical products, and Change Control projects.

Continue to maintain all responsibilities listed under QA Supervisor – In Process Control position.

QA SUPERVISOR – IN PROCESS CONTROL (QAIPC)

Enzon Pharmaceuticals, Inc., Indianapolis, IN – 1/2002 to 7/2004

Note: Same Facility - Company Name Elan from 1/2002 to 11/2002

Supervise the QAIPC Staff of QA Inspectors and Compliance Associates. Coordinate inspections, investigations, internal audits and review of batch records related to manufacturing, filling and packaging activities.

Manage the incoming acceptance sampling and inspection for packaging and labeling supplies. Maintain files of Material Specifications and SOPs; ensure that all QAIPC controlled documentation is current and complete.

Develop and approve in-process sampling inspections plans. Organize the performance, evaluation, and verification of in-process sampling and inspection.

Member of the Material Review Board. Review investigations resolution and reporting of manufacturing incidents, deviations and OOS results.

Prepare and revise QAIPC Material Specifications and SOPs. Ensure that specifications and SOPs meet current standards.

Train Manufacturing and Quality Assurance personnel on current GMP trends and issues. Provide guidance for current regulations and company policies.

Review and Approve Deviation Investigations.

Perform Customer Complaint investigations.

Approve and review Item Master Maintenance Requests and Bill of Material Forms.

Approve labeling and packaging components artwork folders.

QUALITY ASSURANCE COMPLIANCE AUDITOR

Aventis Behring, Kankakee, IL – 12/2000 to 1/2002

Note: From 1988 through 2002 the facility underwent several name changes:

Rorer, Rhone-Poulenc Rorer, Centeon, Aventis, and Aventis Behring

Direct contact with FDA inspectors and other third party regulatory inspectors. Expedite the inspector’s requests, assure accuracy of documentation provided. Assist with responses to observations. Track and facilitate the completion of corrective actions.

Provide compliance guidance to manufacturing and supporting departments. Communicate compliance improvement recommendations and provide guidance regarding interpretation of regulatory mandates. Prepare and distribute compliance metrics.

Conduct internal audits. Verify that the facility is in compliance with cGMPs, international regulations and established internal policies and procedures.

Conduct external audits. Verify suppliers provide materials/services in accordance with cGMP requirements and applicable guidelines.

Perform Regulatory impact reviews. Determine regulatory reporting, cGMP compliance and operational impact for document changes, planned process modifications, and deviations.

Prepare/review necessary regulatory submission documents. Audit Regulatory submissions for accuracy and completeness of the submission and that the conclusions presented are supported by the raw data.

IN-PROCESS PRODUCT QUALITY CONTROL SUPERVISOR

Aventis Behring, Kankakee, IL – 9/1998 to 12/2000

Support quality manufacturing of biopharmaceutical products by providing QC presence on the manufacturing floor.

Perform audits of the manufacturing facilities and procedures.

Track and trend comments and process deviations.

Review critical steps in manufacturing procedures.

QUALITY CONTROL ANALYST

Aventis Behring, Kankakee, IL

9/1991 to 9/1998, Analyst II

10/1988 to 9/1991, Analyst I

SUPERVISORY EXPERIENCE

Manage daily laboratory schedules. Document assay results, apprise manufacturing supervisors of sample status.

Uphold laboratory supply inventory. Communicate with vendors and personnel in purchasing and accounts payable, maintain records, and prepare reports.

Instructor for test procedures. Includes sample preparation, animal handling, equipment set up and maintenance, sample analysis and data calculations.

Department safety inspector and auditor. Report findings to department manager and request necessary maintenance repairs.

LABORATORY EXPERIENCE

Conduct in-vitro and bioassays in a pharmaceutical biology laboratory in accordance with GLP’s and cGMP’s.

Volunteered in the chemistry laboratory to support new product development.

RESEARCH / VALIDATION EXPERIENCE

Co-authored a validation report to change analysis method from auto analyzer to micro titer plate reader. Resulted in a 75% reduction in analysis time and in more accurate data by running samples in duplicate rather than singly.

Played an essential role in team discussions, project planning and report preparation. Performed supportive testing, compiled data into tables and charts, wrote new methods, and revise old methods.

Perform certification testing of HEPA filter systems. Includes: integrity test filter surfaces and housing, seal leaks, measure velocities and volumes, check laminarity, calculate room air changes per hour, generate forms and paperwork for testing procedures, and sterile gowning procedures.

Equipment: aerosol photometers, velocity meters, volume flow hoods, smoke generators, MEC Aerial work platform, calculator, screwdrivers, caulk gun, pliers, wrenches, air hoses and adapters for hook up to high pressure air or nitrogen tank, channel locks, tape measures, and socket sets.

COMPUTER EXPERIENCE

Was an essential member of the SAP Project Team that set up and implemented the SAP programming in nine months. Provided QA guidance, wrote procedures for performing quality functions within SAP, wrote and participated in SAP functionality testing. Performed training on Quality functions within SAP.

Was an essential member of the team assigned to replace the current ERP system (MFG/Pro) with the MS Great Plains ERP system. Provided QA guidance, participated in testing, and ensured timely review of testing.

Proficient in Microsoft Office Programs (Word, Excel, Power Point, Visio, Access, Project, and Outlook), SAP, QTS Pilgrim Software, Novell GroupWise, Internet Explorer, Weber Legitronic Label Marking System, and LIMS.

TRAINING CERTIFICATION

LAL Testing: Drugs, Medical Devices, and Biotechnology - The Center for Professional Advancement

LAL Methodologies, testing protocols, and regulatory guidelines - BioWhittaker, Inc.

Hazardous Waste and Emergency Response Refresher Course - DTA, Inc.

Industrial First Aid - Riverside Medical Center

GHA Pre-Qualification and GMP Compliance Auditing – Max Graber, Aventis-Behring

SEMINARS / SHORT COURSES ATTENDED

Auditing for GMP - Mr. David E. Jones, GMP Institute

Certified Quality Auditor Refresher Course - American Society for Quality

Certified Quality Management Refresher Course - American Society for Quality

Analytic Trouble Shooting Course - Kepner Tregoe

Assay Validation Basics – Lynn Torbeck, Torbeck and Associates

Statistics Using Excel for Laboratory Analysis and Assay Validation – Lynn Torbeck, Torbeck and Associates

A Comprehensive Look at O.O.S. Guidance and Regulations – Lynn Torbeck, Torbeck and Associates

Teamwork – The Carroll-Keller Group Ltd.

Interpersonal Negotiating Skills – The Carroll-Keller Group Ltd.

EDUCATION:

Masters in Management, May 2009, GPA 4.0

University of Phoenix – Online Campus

Bachelor of Science, May 1988

Northern Illinois University, DeKalb, Illinois Major: Biology Minor: Chemistry

Associate of Science, May 1985, Summa Cum Laude

Kishwaukee Community College, Malta, Illinois

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