Regena Bough

*** ******** ******

Worthington, IN 47471

812-***-****

adxgz0@r.postjobfree.com

Objective: To be an integral contributor to the company's mission, vision, values, reputation, and growth by providing the highest level of customer/client service and satisfaction. PROFESSIONAL EXPERIENCE

CATALENT, Bloomington, IN

November 29, 2021 – Present

Senior Quality Engineer

Senior Investigator, MS&T

• Independently investigate biopharmaceutical operations and facility deviations.

• Write complex technical reports documenting actual conditions and the requirements defined by quality standards.

• Identify probable root cause and determine the best solutions for improvement of manufacturing processes, SOPs and business practices.

• Manage multiple priorities and deadlines to meet critical deadlines.

• 17 years of GMP and GDP experience in a regulated industry. COOK MEDICAL, Spencer, IN

April 1. 2019 – November 26, 2021

Quality Engineer

• Perform root cause analysis, investigations, and dispositioning of non-conformances.

• Able to assess risks to provide recommendations to support production activities.

• Create and approve Change Orders.

• Perform scope, containment, and escalation activities.

• Analyze complex data to make data driven decisions. BOSTON SCIENTIFIC, Spencer, IN

March 14, 2005 – March 14, 2019

Quality Engineer Technician IV

• Technical writing.

• Assist Quality Engineers in the following activities: Process validation; Design verification/validation; Product documentation; Statistical Process Control; Product inspection and testing; Qualitative and/or Quantitative data analysis; Continuous Improvement projects; CAPA activities; Project tracking plans; Assessing product risk; Problem solving activities; Non-conformance investigations.

• Assures that appropriate resources are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

• Perform water samples for microbiology testing.

• Quality support for all production areas.

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

• Comply with regulatory requirements including ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions.

Clerk II, Documentation/Manufacturing Execution System (MES 4.5) Implementation Team

• Create and run tests orders for new software upgrade MES 4.5.

• Create, update, and approve PFMEAs, Master Validation Plans, GOIs and SOPs.

• Trainer and MES 4.5 support for Material Control and Manufacturing Operators. EDUCATION

Indiana Wesleyan University, Marion, IN

Bachelor of Science: Business Management

Oakland City University, Oakland City, IN

Master of Science: Strategic Management: Quality Systems Specialization

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