Yyyyyy x. yyyyyy

Consultant Pharmaceutical, Biopharma and Medical Device Industries

Microbiology ~ Biotechnology ~ Regulatory Compliance ~ Root Cause Analysis ~ Troubleshooting

cGMP & GLP ~ QMS ~ Mentoring ~ CAPA ~ International Experience ~ Training ~ Team / Project Leadership

         Offer 20+ years experience on a global scale with extensive experience in consent decree situations.

         Fluent in Spanish with advanced analytical, organizational, technical writing, and troubleshooting skills.

• Excel in conducting investigations and trend analysis, identifying root cause, and steering CAPAs.
• Strong talents in current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and lab safety rules and regulations including hazardous materials management, OSHA compliance, and chemical hygiene.

         Well-versed in Kepner-Tregoe problem solving theory, QMS (Quality Management System), sample collection and processing, data analysis, verifying test results, and documenting findings.

• Proven ability to understand and communicate clinical and technical information, work in cross-disciplinary teams, and handle project tasks independently according to demanding schedules.

         Attended ongoing professional seminars throughout career covering topics such as aseptic processing, EtO sterilization, quality control within microbiology labs, and DEA regulations of controlled products.

Consulting Projects - 2011 to Present:

Senior Consultant 2016 to Present

         Assess and remediate massive mold contamination in a sterile/non-sterile biopharma company as SME in microbiology and QMS following FDA 483 observations.

         Conduct and review investigations, critically evaluate test methods, and provide practical alternatives to client for thorough remediation.

Senior Consultant 2016

         Provided influential expertise and guidance in areas of microbiology, QMS, environmental monitoring for aseptic processing, laboratory operations, and handling of OOS at start-up pharmaceutical facility in Ohio.

Senior Consultant 2015 to 2016

         Functioned as microbiology SME in CAPA remediation plan at aseptic pharmaceutical facility in the UK.

Senior Consultant 2015

         Spearheaded data integrity review and delivered in-depth technical support throughout microbiology and manufacturing areas at aseptic pharmaceutical facility in Italy.

Senior Consultant 2015

         Remediated microbiology laboratory and sterilization processes at medical device facility in New Jersey.

Senior Consultant 2013 to 2015

         Orchestrated remediation of EtO sterilization program at medical device facility in Germany including initial assessment and execution of corresponding CAPAs.

         Mentored, coached and directed Sterilization Manager, and played a lead role in training new sterilization specialists.

Senior Consultant 2011 to 2013

         Mentored and advised laboratory staff at parenteral facility at North Carolina following receipt of warning letter.

Continued ►

Professional Experience continued Yyyyyy x. yyyyyy Page 2 of 2

Bristol Myers Squibb, Manat , P.R., 2011

Senior Microbiology Supervisor

         Proficiently coordinated environmental monitoring of aseptic cores, including two manufacturing isolators.

         Launched investigations, accurately determined root causes, improved manufacturing processes and facilities, and effectively supported aseptic processing activities through cutting-edge isolation technology.

         Trained, coached, and mentored lab personnel in root cause analysis technologies and methods.

Stryker, P.R., 2008 to 2010

Sterility Assurance Advisor / Microbiology Supervisor

         Awarded promotion following exceptional performance in directing EtO and Gamma sterilization processes, troubleshooting EtO sterilization processes, environmental control of clean rooms, assessing biocompatibility, coordinating product releases, documenting DHR, and providing first-rate customer technical support.

Pharma Serv, 2006 to 2008

Sr. Validation / Compliance Specialist

         Handpicked as leader of investigation team at Wyeth tasked with performing root cause analysis for laboratories, utilities / engineering and aseptic manufacturing processes following issuance of warning letter.

         Prepared risk assessments for FDA and facilitated training in technical writing, documentation pitfalls, root cause analysis, and cGMP across several pharmaceutical companies in Puerto Rico.

PHDS Corporation, 2006

Project Manager

         Governed critical microbiology projects related to qualification of equipment, development of testing methods, and creation of training modules in order to meet or exceed QA targets.

Mayne Pharma, Aguadilla Operations, 2005 to 2006

Microbiology Manager

         Instituted laboratory controls and quality systems while overseeing all facets of operations within microbiology laboratory at an aseptic manufacturing site.

Schering Plough Products L.L.C., Manat Operations, 2004 to 2005

cGMP Workplan - Microbiology Team Leader

         Championed full-scope implementation and compliance of quality systems (including alignment of SOPs with USP/EP and training modules) according to regulatory agencies such as FDA and EMEA.

Merck Sharp & Dohme, Barceloneta P.R., 2003 to 2004

Supervisor

         Successfully revised long-standing, obsolete testing SOPs to standardize and optimize operations within microbiology laboratory.

         Devised working modules to optimize productivity despite staffing reduction of 13 to eight microbiologists.

Schering Plough Products LLC, Manat Operations, 1993 to 2003

Senior Analyst

         Formulated and prepared culture media, validated sterility, and identified microorganisms via both conventional systems (API and Minitek) and automated systems such as Vitek and MIDI.

         Provided technical training to microbiology personnel while supporting broad-based analytical efforts.

Supervisor, Microbiology Labs (Technical Services)

         Applied dynamic leadership talents toward directing team of 10 microbiologists in conducting OOS laboratory investigations encompassing raw materials, finished goods, environmental monitoring, and water systems.

         Chosen as Interim Dept. Manager charged with setting up laboratories operations within consent decree situation.

Quality Assurance Specialist II

         Supported QA functions by conducting laboratory investigations, generating MRB reports, training and certifying employees in root cause analysis, and providing technical support to microbiology laboratories.

B.S. in Biological Sciences, Specialization in Microbiology & Mycology, University of Puerto Rico-Mayag ez

Yyyyyy x. yyyyyy

(DATE)

(HIRING AGENT NAME)

(TITLE)

(COMPANY NAME)

(ADDRESS)

(CITY/STATE/ZIP CODE)

Dear__________________:

I am currently seeking a challenging career opportunity in a senior-level consulting capacity and am submitting my resume for your review. In advance, thank you for your time and consideration.

In addition to a substantial scientific background and consulting expertise, I bring to you solid experience in directing regulatory compliance for laboratory operations, outstanding expertise in quality assurance management, and an exemplary blend of talents in SOP development, root cause analysis, team leadership, training, and management of mold infestations within manufacturing facilities. To complement these qualifications, I offer extensive experience within the pharmaceutical industry with specialization in microbiology. I have also championed numerous investigations mandated by the FDA for companies under warning letter or consent decree status.

As a proactive contributor to your organization, you will find me to be a highly motivated professional committed to supporting you in achieving your objectives through superior dedication and self-initiative. I am confident that I could be a valuable asset to <INSERT NAME OF ORGANIZATION> and encourage you to contact me at the information listed above.

Sincerely,

Yyyyyy x. yyyyyy