** ***** **/ ****** *****, CA *****

Phone: 510-***-**** / Fax: 650-***-****

Email: adzimj@r.postjobfree.com

MICHAEL MAROON

PROFESSIONAL PROFILE

An experienced QA/QC professional with expertise in innovative approaches to quality subsystem improvement. Ability to implement complex plans within regulated industries. Particularly effective implementing collaborative leadership principles for inspection readiness, including project management and investigation/CAPA management. The proven ability to recruit, hire, and maintain high performance teams.

—Skills & Attributes—

Over 20 years in QA/QC serving Biopharma, Small Molecule and Medical Device Class II & III commercial and over 5 years in Phase 1, 2, and 3 Clinical QA. Have successfully managed product release activities/batch record review, audit readiness, quality systems (deviations/investigations, CAPA) management, QC, Customer Complaints, Document Control, Change Control, Calibration, Validation, Microbiology, Environmental Monitoring, and trend reporting. Have worked with Production to implement Lean Manufacturing principles including 5S, value stream mapping, Kaizan efforts, and Statistical Process Control. Have authored Drug Master Files, Site Master Files, and Annual Product Reviews. I have authored and reviewed multiple sections of New Drug Applications; and demonstrated the ability to trouble-shoot complex issues and execute timely decision making in manufacturing and testing facilities.

REGULATED INDUSTRIES

Black Diamond Consulting (Quality consultant for Janssen Pharmaceuticals) Mar - Jun 2023.

Three-month project to close legacy QC investigations for clinical QA. Specialized in performing investigations related to EM/HVAC systems. Assignment completed in 4 months. Legact backlog of QC investigations completed.

Delta Project Management/Verista (Quality Consultant for Honeywell & Novartis) 2021/2022.

Project Manager for AZ/Honeywell GMP audit preparation; facilitated moving ISO certified site to GMP audit readiness. Work streams identified were legacy computer system validations, implementation of cGMP QC laboratory release testing, GMP production unit construction, qualification & validation, method transfer, and development of Quality System documentation. Hosted successful mock audit by 6 AstraZeneca visitors in Apr 2022. Successful final audit in June 2022. Through collaboration and mentoring behavior blended two coworkers into a productive, cohesive, high-performance team.

ALKU (Quality consultant for Lonza) – 2020/2021

Quality oversight of QA Validation (Clinical Bulk manufacturing) for 2020 shutdown and specialized investigations related to EM/HVAC systems. Authored Quality Plan for legacy revalidation assessments.

NEOZENE (Quality consultant for Intersect ENT) - 2019

Clinical deviation management, CAPA, Micro/EM and commercial/clinical Customer Complaints.

Making You Better Brands (Topical cannabis and CBD products) 2018/2019

Authored 48 Standard Operating Procedures and related batch records, developed a Quality System which included 5S of the manufacturing facility, inventory control via tracking spreadsheet, approved vendor list, training SOP, training presentation and a variety of additional documents. This was a part time position, 20 hours per week for friends on a pro bono basis.

NEOZENE (Quality consultant for Natera) 2017

Clinical combination drug and device. Performed five internal audits: Internal Audit process, Risk Management, Design Control, Equipment Installation & Qualification and Deviation/CAPA management. Reviewed and approved 56 IQ, OQ, PQ and other requalification documentation. Performed a gap assessment of ISO 13485-12 and ISO 13485-16. Covered for an employee on childcare leave.

ALKU (Quality Consultant for Impax Laboratories) 2017

Project Manager responsible for commercial Customer Complaints, opening the Customer Complaint in Trackwise, ensuring timely investigations (CMO’s and Impax) and timely Complaint closure. Closed all legacy items and completed contract.

ALKU (Quality Consultant for Gilead) 2015/2016

Project Manager responsible for clinical Deviation Management, closure of CAPA’s, customer complaints, internal audit observations and open change controls. Was responsible for complex investigations working with aseptic and solid dosage form filling and intermediates at CMO’s. Facilitated weekly deviation and CAPA meetings, composed agendas and meeting minutes. Responsible for continuous improvement of deviation and CAPA systems, met weekly with ten different CMO’s to ensure open issues were closed in a timely manner. The contract ended in Sep 2016.

Delta Project Management (Quality Consultant for Pearl Therapeutics) 2014/2015

PAI Project Manager, facilitated bi-monthly core team meetings and weekly sub team meetings with QA, QC/Analytical, Manufacturing, Training, and Equipment teams. Tracked and monitored completion of 400+ items identified for PAI readiness. Helped prepare for a successful mock audit. Project completed in Aug 2015.

Exelixis Inc., Senior Manager QA 2013/2014

Quality oversight of international and stateside CMO’s which included deviation resolution, CAPA closures, Customer Complaint investigations, and batch record review. Conducted routine external audits of testing and distribution organizations, performed PAI mock audit of CMO’s for inspection readiness. Authored the initial Annual Product Review for Exelixis’ first commercial product. Exelixis laid off 70% of the organization in Nov 2014.

Delta Project Management (Quality Consultant for Alexza Pharmaceuticals) 2012/2013

Clinical combination drug and device. Completed legacy discrepancy investigations including performance of systemic investigations and CAPA assessments to support pre PAI activities. Completed CAPA implementation via creation of new SOPs, document revisions, etc. Supply Chain and Calibration system internal audits & compliance remediation. Project completed in Mar 2013.

PCT Cell Therapy, Director QA/QC 2011/2012

Site Quality Management Representative for CMO performing cGMP Phase I, II, and III clinical trials.

Directed Product Release activities, client/regulatory body inspection readiness and internal/external audits. Hosted four successful client audits from 2011 to 2012. Directed non-conformance and Customer Complaint investigations, root cause analysis and CAPA implementation. QA/QC staff of nine and department budget of 1,000K. Business downturn led to company lay-offs, Jul 2012.

Bio-Rad, Manager QA/QC 2008-2011

Site Quality Management Representative for Class II Medical Device. Primary quality contact with CMO’s to resolve QA/QC issues. Managed non-conformance investigations in Class 100,000 and 10,00 areas, root cause analysis, CAPA implementation and internal/external audits. Oversaw Customer Complaint investigations and related corrective actions. Facilitated Quarterly Management Reviews and tracked to closure related corrective actions. Responsible for inspection readiness and was the host for five successful audits from June 2009 to Aug 2010 (ISO 13485 -TUV, Internal, state FDA, ISO 13485-LNE/GMED, federal FDA). Culminated in FDA Inspection from 02-03 Aug 10 that resulted in the most successful inspection ever at Benicia Bio-Rad. QA/QC staff of eight and a department budget of $775K. Bio-Rad decided to move this satellite site to Irvine, CA. I did not relocate.

Solstice Neurosciences, QA Associate Director 2007/2008

Managed deviation Fermentation, Purification, Formulation and aseptic fill investigations, root cause analysis, CAPA and Customer Complaint implementation. Oversight of Change Control, including review and approval of all document changes, Validation protocols, reports, Quality Agreements. Authored the 2007 and 2008 Annual Product Reviews. Quality contact to resolve quality issues with CMO used for aseptic filling. Responsible for internal/external audits, inspection readiness and was the host for a successful January 2008, Korean FDA Pre-Approval Inspection. QA staff of three and a department budget of $350K.

Chiron, QA Microbiology/Environmental Monitoring Manager / Quality System: CAPA and Change Control Manager / Novartis, QA Validation Manager 1988-2007

QA Validation subject matter expert on the Aseptic Processing Area (APA), validated HVAC systems, clean utilities, and microbiology/environmental monitoring. From 1996 – 2001 was responsible for Environmental Monitoring (viable, non-viable, surface and personnel) in the aseptic filling area. Responsible for Formulation and aseptic filling microbiological investigations. Responsible for QA Validation review and approval for Change Control and Validation documentation (>300 documents per year from 2003 through 2006). Oversight and management of the Corrective and Preventive Action (CAPA) System, my team closed >1200 open CAPA’s in 3 years via initiation of cross functional teams to address open issues. Led multiple cross functional teams to complete investigations for over three hundred discrepancies in 2001-2002. Was the FDA representative for the CAPA and Change Control systems. Quality Systems staff of 5 (with two associate managers) and a department budget of $550K. QA Microbiology/Environmental Monitoring had a staff of eight with a budget of $900K.

EDUCATION

Continuing education throughout career

1988 - B.S. in Microbiology from CSU Chico

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