Software Developer Quality Engineer

Mark Petersen

ANCHORAGE, AK ***** • WEBSITE HTTPS://MARKUSPETERSEN.COM

PHONE 503-***-**** • E-MAIL ***********@*****.***

QUALIFICATIONS

Proven quality systems professional, positioned for career pivot to software systems development, quality / testing or data analysis. Recent software development boot camp graduate seeking a fulltime, part time or contract opportunity to contribute to project success and user satisfaction. Resume highlights:

Quality Systems: Seven years of experience in pharmaceutical and medical device quality management from FDA approval and compliance / regulatory processes to internal audits and compliance process ownership.

Software Development: Completion of training and code development projects (backend, frontend) using SQL, C#, HTML, CSS, .NET Framework, JavaScript, Visual Studio, and Python with best practices in version control (Git) and agile methodology.

Data Analysis and Communications: Proficient in all Microsoft Office applications, ETL databases, and ERP systems (SAP) for analysis and communication of information in formal reports, project meetings and executive reviews.

Teamwork and Collaboration: Served as team lead and project manager on several multi-departmental CAPAs (corrective and preventative action) and internal audits. Noted for excellence in working with diverse, multi-cultural teams.

PROFESSIONAL EXPERIENCE

BIOTRONIK, Inc (www.biotronik.com) Lake Oswego, OR

Compliance/Quality Specialist December 2015 – May 2018

Established and managed OEM Supplier Evaluation Process including development of Quality Agreements representing multimillion-dollar sales opportunities.

Performed internal audits and managed resulting corrective actions.

Developed and maintained quality project dashboards throughout project lifecycle including key performance indicators and milestones for executive review.

Participated in FDA facility inspections at BIOTRONIK, Inc.(USA) and preparation of annual FDA reports as required for products and devices that have been approved by pre-market approval (PMA) process.

Genentech Inc. (member of Roche Group, www.gene.com) South San Francisco, CA

Quality Assurance Specialist II (full time contractor) October 2014 – December 2015

Recruited for regulation and QA of Genentech’s strategic CMO initiative with Samsung BioLogics.

Managed activities to support release of commercial product including approval of master process documentation, resolution of investigations, and assessment of change controls.

Developed and maintained quality risk management plans ensuring CMO inspection readiness.

Berkeley Advanced Biomaterials Inc. (www.hydroxyapatite.com) Berkeley, CA

Quality Assurance Specialist II March 2014 – October 2014

Responsible for CAPA (corrective and preventative action) from initiation to effectiveness verification.

Developed and conducted formal group training on CAPA best practices.

Managed QC processes and streamlined existing systems to maximize process efficiency.

Collaborated with external testing partners in result analysis of various biological testing equipment.

CAPA / Complaint Coordinator April 2012 - March 2014

Responsible for management of all CAPA reports, deviations and complaints.

Accountable for data management for regulatory and certification of compliance.

Worked across departments to investigate and close process issues and product complaints.

Served as backup to quality control technician and quality engineer performing functions such as new product validations, manufacturing equipment calibration and maintenance program.

Genentech Inc. Hillsboro, OR

Inspections Technician (full time contractor) April 2011 – April 2012

Responsible for final packaging and inspection of commercial pharmaceutical products.

Trained in process knowledge for full compliance of cGMPs, Standard Operating Procedures (SOPs).

Assigned to a process improvement task force utilizing SWOT and other system analysis tools.

EDUCATION

Tech Academy – Software Developer Boot Camp September 2018 – January 2019

(www.learncodinganywhere.com)

1,000 hours software development training using C#, Python, JavaScript, HTML, CSS, SQL, & Git

Front-end and back-end web and software development projects (samples available on GitHub)

Training included best practices for version control, agile methodology, project management

Johns Hopkins Nuclear Medicine Technology Program June 2010 – February 2011

Johns Hopkins Hospital, Baltimore MD

Completed 500 in-clinic service hours towards nuclear medicine technologist training (25h/week)

Course completions in nuclear medicine technology, medical terminology and disease diagnosis

Bachelor of Science, Chemistry Degree Awarded: January 2010

University of Oregon, Eugene OR

ADDITIONAL SKILLS & CERTIFICATIONS

Tech Academy (www.learncodinganywhere.com)Software Developer Boot Camp graduate.

Trained in cGMP standards, SOP’s for global pharmaceutical production.

Proficient in: Microsoft Office Suite, Visio, WEBEX, Oracle, TrackWise, SAP, Livelink, VisualStudio, Git

Experienced in investigative and system mapping tools, Lean six sigma project methodology and tools.

Knowledgeable in certifications and government regulations such as /EDQM standards.

Six Sigma Yellow and Green Belt (Oregon State University, ASQ certified #17926).

ASQ Certified Quality Process Analyst (#65314868 – 5050.

ASQ Certified Quality Auditor (#65314868 – 66408).

ASQ Certified Quality Engineer (#101354).

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