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Quality Management

Location:
Denver, Colorado, United States
Salary:
75000.00
Posted:
September 12, 2018

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Resume:

Lillian E. Lynn

Westminster, CO ***** 303-***-**** ac607e@r.postjobfree.com

Summary of Qualifications

Highly experienced Quality Professional with a combined blend of medical device and pharmaceutical cGmp experience. Areas of expertise include:

-cGMP/GDP/FDA/ISO Audit Experience -Medical Device, Pharmaceutical and Injection Molding experience

-Regulatory process oversight/MDR Filing -Quality System Development, Management, Improvement

-Complaint/Deviation Processing -Project Management/Team Building and Leadership

Professional Experience

Medtronic 2/2017- Present. Louisville CO. Complaint Specialist.

Investigate and process complaints from global sources.

Interface with internal and external personnel as well as regulatory, compliance and clinical site personnel globally.

File MDRs and related documents

Maintain country specific requirements (Local, OUS/EU/Japan/China etc.)

Report quality metrics to management

Support customer queries, inquiries from the field and from quality, regulatory and engineering personnel

Agilent Technologies 10/2016 – 1/2017. Boulder CO. Contract Compliance Specialist

Technical Writer/Investigator.

Batch record reviewer

Document and investigate deviations, CAPAs and change controls in a ICH/GMP API pharmaceutical environment.

Document management; revise SOPs and quality documents. Technical file remediation team

Pfizer/Hospira (Corden) 6/2015 – 9/2016. Boulder, CO. Quality Control Contractor.

Collaborated with the QA and QC departments to bring CAPAs and document revisions to closure.

Conducted deviation investigations, root cause analysis, product impact analysis and closure.

Maintain electronic databases and act as liaison between regulatory, quality assurance and quality control teams

Maintain department training records, LMS database and revise/generate SOPs and manuals

Technical file remediation/Change control/Batch record review

Support customer queries, inquiries from the field and from quality, regulatory and engineering personnel

Report quality metrics to management

American Intercontinental University 11/2009 – 2/2017 Adjunct Assistant Professor, Schaumburg, IL. Courses taught: Strategic Management, Regulatory Compliance and Business Management. Student advising, course development and revision.

Everest University 2/2014 – 4/2015 Business Faculty, Remote. Taught Business Management. Collaborated with leadership team on process improvement initiatives.

Jabil (Nypro) Healthcare 7/2009 – 4/2011 Quality Assurance Operations. Gurnee, IL.

Conducted deviation and product impact investigations, root cause analysis, and closure.

Present at numerous ISO and client audits

Review and approve batch records, labeling, device records (DHR/DMR)

Reviewed and approved Quality Assurance documentation: SOPs, complaint files, audit performed floor audits.

Responsible for managing direct and indirect reports.

Technical file remediation

Batch record review lead

Lead Internal Auditor certified (cGMP).

Accountable for documentation, quality, regulatory activities, customer complaint investigation, internal and external audits, process validation.

Managed projects from inception through implementation and closure.

Trained new personnel on the CAPA and audit process

Support customer queries, inquiries from the field and from quality, regulatory and engineering personnel

Report quality metrics to management

College of Lake County 1/2006 - 5/2006 Adjunct Electronics Instructor, Grayslake, IL.

Prepared and facilitated Electronics Engineering Technology classes. Coached students on a variety of issues such as academic advising and career planning.

Plexus Electronic Assembly 11/2002 – 9/5/2008 Regulatory Operations, Buffalo Grove, IL.

Managed inter-departmental projects, including quality, manufacturing and regulatory compliance events.

Represent department at numerous FDA, ISO and client audits

Reviewed and approved Quality Assurance documentation: SOPs, complaint files, audit reports, batch records and CAPAs.

Shared management responsibilities for 15 Subject Matter Experts with responsibility for evaluating, scheduling and training.

Conducted training for incoming employees

Coordinating with regulatory personnel globally to assure compliance with regional, national and global regulatory requirements (such as QSR).

Lead Internal Auditor (cGMP)

Managed QA projects from inception through planning, implementation and closure

Technical file remediation

Support customer queries, inquiries from the field and from quality, regulatory and engineering personnel

Batch record review team member

The Buffalo Grove site was recognized as the “Best Site” for compliance, globally corporate wide for the years 2006-2008.

LEL Enterprises Inc. 9/2008 – 9/2013 Founder.

Full service training and consulting firm. Implementing creative solutions along with customized strategic goals that delivered the desired outcome.

Extensive experience in process/project management that included developing and tracking projects using metrics.

Education

AIU Online, Hoffman Estates, IL MBA Human Resources.

AIU Online, Hoffman Estates, IL MBA Management

Southern Illinois University, Carbondale, IL B.S. degree Aviation Management. Coursework completed toward M.S. Ed.

Daley College, Chicago, IL Associate Degree - A.A.S. in Aviation Maintenance

Military Experience

US Naval Reserve

Jet engine mechanic (AD3)

Military police officer

Certified trainer and administered training on topics from military procedure, police regulations, tactics and strategy, communication and conflict resolution.



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