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Quality Management

Location:
St. Louis, Missouri, United States
Salary:
85000
Posted:
June 13, 2018

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EDUCATION

Purdue University August ****

Bachelor of Science in Health Sciences

Minors in Chemistry and Occupational Leadership & Supervision

Additional Training

Six Sigma Green Belt Team Training: Covance, Indianapolis, IN and Eli Lilly, Indianapolis, IN

Presentation Skills: ExecuTrain, Indianapolis, IN

Accomplishments

Hosted FDA audits at Covance in 2005 and 2006 for Bioanalytical Review of Clinical Studies with No 483 Observations

Certified and completed of an expansion at AmbioPharm in 2014.

Established ISO Cleanroom Standards for AmbioPharm in 2014 (Class 7 and Class 8)

Key Skills

Proficient or familiar with the following:

MiniTab & SPSS (statistical program)

GxP Regulations

TrackWise

eQA (electronic Quality Assurance database)

Darwin and Nautilus LIMS systems

Empower

Multitasking projects to completion

CAPA trained via MWSQA and Eli Lilly

Manager and conduct Internal and External Audits (both suppliers and contract labs)

Mentor and train teammembers

PROFESSIONAL EXPERIENCE

12/2016 – 01/2018

Senior Quality Assurance Associate, Patheon (now part of Thermo Fisher)

Comply with all job-related safety and other training requirements. For processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements, write new procedures and ensure adherence to current regulations. Ensure quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes. Conduct risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks. Act as a technical resource for support of systems and new product introduction by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems. Perform QA batch disposition (release) decisions. Hosted regulatory and client audits pertain to PAI submissions.

06/2015 – 11/2016

Quality Inspector Level III, MOX: Department of Energy

Perform receipt inspection as necessary to verify conformance of suppler fabrication specifications to assure implementation of the project procurement requirements. Utilize measuring and test equipment in the performance of inspections. Participate in on-the-job training to develop skills to assure fabrication meets procurement specifications, drawing and work instructions. Identify conditions adverse to quality. Assure, if applicable, that further processing, installation, or use is controlled until proper disposition of a nonconformance, deficiency, or unsatisfactory condition has occurred.

09/2014 – 06/2015

Quality Supervisor; AmbioPharm Inc.

Ensure decisions are made in accordance with external and internal regulatory compliance expectations for API production. Communicate and coordinates with other departments and customers as required for quality related issues. Manages the review and approval of Production Batches in “Clean Room Environment” and QC testing records for final product release. Ensures quality systems are compliant and efficient. Actively participates in customer and FDA audits. Responsible for elaboration of regulatory strategies to support development and lifecycle of API’s and drug products in the United States, Europe, and emerging countries. Responsible for definition and management of worldwide quality systems for development and commercial pharmaceutical activities. Implement and train employees on Risk Assessment. Create stand operating procedures (SOPs) and test procedures and follow regulatory agencies and customers. Responsible for managing the change control process. Performed and maintained vendor audits and approval of raw materials for production on API material. Hosted and was the “face of the company” to external clients. Maintain complex files and document management systems, and work with project teams to release company products. Assist in the management of project timelines and provides operational regulatory support to project teams and Senior Management. Actively auditing and training the manufacturing staff as the in-plant Quality representative. Managed and conducted Internal Audits. Led preparation and facilitation of regulatory and/or client inspections. Ensured processes were sustainable for potential inspection readiness. Mentored team on current FDA guidelines and expectations. Conducted mocks audits with the anticipation of regulatory audits.

08/2014 – 09/2014

Senior Quality Assurance Associate; AmbioPharm Inc.

Ensure decisions are made in accordance with external and internal regulatory compliance expectations for API production. Communicate and coordinates with other departments and customers as required for quality related issues. Manages the review and approval of Production Batches in “Clean Room Environment” and QC testing records for final product release. Ensures quality systems are compliant and efficient. Actively participates in customer and FDA audits. Responsible for elaboration of regulatory strategies to support development and lifecycle of API’s and drug products in the United States, Europe, and emerging countries. Responsible for definition and management of worldwide quality systems for development and commercial pharmaceutical activities. Implement and train employees on Risk Assessment. Create stand operating procedures (SOPs) and test procedures and follow regulatory agencies and customers. Maintain complex files and document management systems, and work with project teams to release company products. Assist in the management of project timelines and provides operational regulatory support to project teams and Senior Management. Actively audit and train the manufacturing staff as the in-plant Quality representative

03/2013 – 08/2014

Quality Supervisor - Consultant

Primary responsibilities are to bring a logistic company interested in entering the pharmaceutical industry for transportation and storage. Responsible for generating SOP, filing for applicable state pharmacy licenses, training, and ensure facility meets with GMP regulations. Provide training on Root Cause Analysis using FMEA (Failure Mode and Effects Analysis) and Impact Analysis for implementing processes. Overseen campus Pest Control Program. Reviewed quarterly trends provided by Pest Control contractor.

02/2012 – 01/2013

Team Leader Quality Control; Eli Lilly

Proactively manage day-to-day business which includes interactions with production planners, sample submitters to manage laboratory workload and throughput. Maintain a high level understanding of the laboratory processes, and be responsible for analyst training on laboratory methods. Develop career plans for laboratory analysts. Enforce compliance to all procedures, methods, and other regulatory commitments. Provide technical understanding of the regulations applicable to laboratory testing for GMP purposes. Participate as primary laboratory contact for internal and external audits. Responsible for maintaining a safe work environment, working safely, and accountable for supporting all corporate and site goals. Mentor other Quality Control team members to build divisional bench strength and knowledge regarding technical skills and applicable regulatory requirements. Provide support as a Lead Investigator for CAPA deviation that arouse in the manufacturing area and laboratory setting.

07/2009 – 12/2011

Proposal Manager; Covance

Reviews requests for proposals (RFPs); develops proposal plans, outlines and schedules; and prepares questions for the potential client. Assembles and reviews the efforts of an appropriate team of partners, consultants, subcontractors, writers, editors, illustrators, desktop publishers, proofreaders and quality control and print reproduction personnel. Guides proposal team writers and financial analysts in preparing the technical and cost components of the proposal, including understanding of the task, plan, past performance and personnel. Reviews proposal draft and final versions for responsiveness to RFP, thoroughness, accuracy, staffing, financial considerations, quality and effective design and layout. Main point of contact for the company at bidder's conferences and during site visits. In addition to work on specific proposals, creates corporate concepts and boilerplate content for use in future proposals. After the each proposal submission, leads post-proposal efforts such as negotiations, contract start-up briefings and "proposal lessons learned" staff meetings.

04/2008 – 07/2009

Study Coordinator II; Covance Bioanalytical Services

Drafts protocols, sample analysis outlines (SAOs), amendments and study schedules using Word and Excel as appropriate; using proposal outline or client-supplied information. Reviews study compliance against protocol, SOP, and regulatory agency guidelines (GLP requirements). Assists in the development of new report format for regulatory submissions as needed. Improves processes to increase the efficiency of daily/routine procedures and reporting methods. Serves as the primary contact in communication and interaction with other departments and clients as applicable. Updates and maintains project tracking systems as appropriate. Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required. Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups. Assists in interpreting and evaluating data for reports. Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable. Reviews QAU report audits. Submits audit responses for approval as appropriate. Creates and distributes weekly backlog reports and help facilitate development of action plans to reduce / eliminate backlog. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines. Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed. Responsible for report productions through finalization, including archival of data as appropriate. Prepares for and participates in routine client visits. Manages data transfer to clients as requested. Assists Study Directors / Principle Investigators in monitoring GLP study phases. Assisted in reviewing pharmakenetic data with Study Directors / Principle Investigator’s guidance.

04/2006 – 03-2008

Quality Assurance Team Leader; Covance Bioanalytical Services

Verifies compliance to applicable Standard operating Procedures and regulations by performing internal protocol, data (pharmacokinetic and bioanalytical), report, in-lab inspections, and supplemental audits in a technical discipline of Bioanalytical Chemistry following GLP and GCP requirements. Main point of contact for external audits either by clients or regulatory agents (FDA). Ensures and coordinates quality checks for accuracy, collates reviewer’s comments, adjusts content of document as required based on internal/external input, and prepares final versions. Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution. Notifies management of observed quality and compliance trends and services failures. Provides management improvement ideas based on new FDA regulations based on White Page discussions. Assists co-workers and internal customers with interpretation of regulatory requirements, SOPs, and other guidance documents. Works with teams to ensure smooth and timely development of documents. Communicates with team members to maintain focus and awareness of potential delays, problems, gaps of information, expectations, project steps, milestones, and deliverables to effectively manage the document process. Effective in collaborations in a team-oriented environment with other associates, technicians, and project leader in the laboratory. Mentor other Quality Assurance team members to build divisional bench strength and knowledge regarding Clinical Operations and applicable government regulations. Performed facility audits to ensure GLP requirements were met at Indianapolis, IN and Madison, WI locations. Tracked laboratory deviation by trending data from Quality Systems and determining Root Causes and communicating trends to laboratory management for CAPA issues. Managed and conducted Internal Audits. Led preparation and facilitation of regulatory and/or client inspections. Ensured processes were sustainable for potential inspection readiness.

09/2004 – 03/2006

Quality Assurance Auditor; Covance Bioanalytical Services

Assists co-workers and internal customers with interpretation of regulatory requirements (e.g., GLPs), SOP requirements, and other guidance documents, as applicable. Performs internal supplemental audits of a technical discipline to verify that facility records (e.g., equipment, training files) are in conformance to applicable SOP and regulatory requirements. Performs internal protocol, data, reports for regulatory submission, and in-lab phase inspections in a technical discipline to verify conformance to applicable SOP and regulatory requirements. Ensures systems used in QA are properly maintained (e.g., QA audit records, training records). Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution. Participates in client introductions, tours, and client audit debriefs. Assists with client audits by retrieving and preparing study data and facility records needed for review. Notifies management of observed quality/compliance trends and service failures. Identifies and participates in process improvement opportunities and harmonization efforts to promote best practices. Followed laboratory procedures and regulatory deviations and verified that laboratory deviation were addressed appropriately.

09/2003-09/2004

US Patient Safety Technician; Eli Lilly and Company via Kelly Scientific

Analyzed returned consumer products, Forteo, Humatrope, and Insulin pens, for deficiencies by using applicable quality control and Standard Operating Procedures, and forwarding observations to appropriate third party quality control department for further investigation.

04/2003-08/2003

Research Assistant; Westat via EPA

Collected, prepared, and preformed antibody specific reactions to identify bacteria and bacterial levels using experimental analysis (Raptor Test) similar to liquid particle counters. Compared group data with that of Lake Michigan Laboratory and United States Geological Survey (USGS). Effective in collaborations in a team-oriented environment with other associates, technicians, and project leader in the laboratory. Followed the EPA guidelines and regulations.

3/2001-8/2001

Intern Formulation Chemist; Halox, Inc.

Provide research and development for compliance testing and verification. Performed stability experiments (corrosion, UV, acid-base, and viscosity) to enhance products resilience based on customer’s specifications.

8/2000-3/2001

Research Assistant; Northwest Center for Medical Education, Indiana University

Grew and cultured human retinal pigment epithelial cells to run electrophoresis gels and Elisas to identify specific protein markers. Also, used photo-spectrometry to calculate protein solution concentrations.

PROFESSIONAL MEMBERSHIPS AND AFFILIATIONS

Current member of Midwest Society of Quality Assurance (SQA) since 2004.



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