Quality Assurance Engineer

Elsa I Cruz

**** ****** **, ***********, ** *****

Cel: 787-***-****, email: ad5vtg@r.postjobfree.com Professional Summary

As a Quality Assurance Professional with over 28 years of experience, I possess extensive expertise in Pharmaceutical Industry: Medical Device, Biotechnology, Solid Oral Dosage industries, and Genetic Diagnostic laboratories. I have held positions of Site Quality Lead, Compliance Officer, Quality Engineer, and Senior Quality Assurance Specialist at FDA and EMA regulated companies encompassing operations including drug substance manufacturing for mAbs, parenteral drug product formulation, fill & finish, small molecule pharmaceutical manufacturing, and genetics-based diagnostics. Strong background in Quality Assurance, Regulatory Compliance and Quality Systems. My strong background enables me to offer guidance to product development teams and ensure site compliance with relevant cGMPs, GDP, GLP, and local SOPs. I have been instrumental in supporting all functions of Quality Management Systems including CAPA, Deviations, Change Control, Design Control, Complaint Management, Supplier Quality Qualification, Incoming Inspection, Facilities & Equipment Compliance, Document Control, Batch Record Review and Batch Disposition. Experience with Validation and Qualification Compliance, Process & Equipment Validation, Risks Assessment, Annual Product Reviews, and deviations. Strong technical writing and oral communication skills, delivering high-quality work within tight time and resource constraints. I have extensive experience developing & executing inspection readiness, internal audit programs for regulatory inspections. Experience with continuous improvement activities, new product introductions activities, and the implementation & monitoring of KPIs metrics. Familiar with Quality Systems Tools such as Trackwise, ASCTrac, EDMS, and LIMS. Results-oriented, capable of working independently as well as part of a team, in fast paced and challenging environments. Fully bilingual (English/ Spanish).

PROFESSIONAL COMPETENCIES AND TECHNICAL SKILLS

● Clinical Diagnostic Laboratory Techniques and Skills.

● Good Laboratory Practice (GLP), Good Manufacturing Practice (cGMP), ICH, USP, Eu. Phr, GxP and GCP requirements.

● Regulatory Compliance, Regulatory Affairs, and Regulatory guidelines, FDA/EMEA/EMA.

● Experience with CLIA, CAP, NYSDOH, FDA laws and regulations and ISO standards

● Proficiency in computer skills including MS Office Suite (Excel, Word, Power Point), Quality Systems Management (QMS)

● mAbs drug substance manufacturing Upstream and Downstream Processes.

● Qualified Auditor (by training and experience): Regulatory inspection readiness and internal audits skills. Quality Audits & Inspections.

● Employee hiring, training, motivating and leading people. Supervisory experience and skills.

● Oral and written communication, and organizational skills and technical writing skills.

● Certified Six Sigma Green Belt (CSSGB) – ASQ.

SEMINARS & PROFESSIONAL DEVELOPMENT

Professional Development: Certified Six Sigma Green Belt (CSSGB), Foundation Skills for Biotechnology for QA Professionals, Basic Skills for Bulk Manufacturing Processes (Cell Culture, Inoculum, Fermentation and Purification), Investigational Skills Workshop, Write Effective Procedures Workshop, Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) Academia. Seminars: Conflict Resolution Workshop, Advanced Auditing Techniques for NDA and cGMP Auditors, Statistical Software. PROFESSIONAL EXPERIENCE

INVITAE CORPORATION, MORRISVILLE, NORTH CAROLINA 01/2021 - 02/2024 Site Quality Lead: Site Quality Lead supporting all Quality Management Systems. Provide leadership and oversight of the site Quality activities to ensure compliance with the Invitae’s Quality Management Systems (QMS). Create, monitor and analyze Quality Performance Monitors (KPIs). Manage site specific Corrective Action Program (CAP) with program Lead, to investigate, analyze and assess non-conforming events, to ensure appropriate root cause identification and corrective/preventive actions implementation. Manage site specific Training and Competency Programs aimed at accurate and timely records completion. Support the Validation Program to ensure GMP compliant facilities and automated sample analysis equipment. Responsible for the quality aspect of site-specific Change Management (Control) Program. Manage the site Internal Audit Program and collaboration with the Global Internal Auditor to perform internal and external audits to define and implement needed corrective actions. Manage the Proficiency Testing Program, track external and internal proficiency surveys, and maintain related documentation. Manage and collaborate with laboratory leaders to ensure audit readiness. Prepare, submit and maintain laboratory licenses, reports and filings required by the accrediting agencies.

Elsa I Cruz

KBI BIOPHARMA, DURHAM, NORTH CAROLINA

Senior Manufacturing Compliance Specialist 12/2018 -12/2021 Perform, lead, and manage Major and Critical deviations related to Manufacturing (Upstream, Downstream, Support, Facility, Supply Chain, and Microbiology laboratory). Coordinate site readiness activities in preparation for clients and regulatory agencies inspections. NC CAPA quality team delegate for high level meetings and CAPA policy implementation. Coordination and distribution of workload within the Non-Conformance and Corrective Action / Preventive Action team. Supported the interviewing, hiring, and training of new Manufacturing Compliance team employees. Acting Associate Director of Manufacturing Compliance during resource sick leave term of 6 months.

Non-Compliance and CAPA Investigator 06/2016 – 12/2018 Perform and lead major and critical investigations related to Manufacturing, Facilities, Materials and laboratory deviations. Interact with Management at all levels in Corrective Action and Preventive Action (CAPA) implementation activities. Gather information from all necessary internal and external sources to evaluate the extent of impact on product quality and risk mitigation in future operations. Provide support to Manufacturing Supervisors and Managers related to Non-Conformance issues and deviations. Participate and coordinate site readiness activities in preparation for Clients and regulatory inspections. ABBVIE BIOTECHNOLOGY, BARCELONETA, PUERTO RICO 12/2013 – 07/2015 Compliance Officer: Internal Audit Program site lead, preparation of audit plans and checklists against applicable standards, drafted the GMPs for the execution of internal compliance audits; preparation of comprehensive written audit reports; follow up of findings until CAPAs completion and closure. Coordinate inspection readiness activities in preparation for quality audits and external regulatory inspections. Perform and lead customer complaints investigations for bulk drug substance and drug product. Develop and issue Product Quality Review (PQR) and Annual Product Review (APR) documents per the scheduled time. Designated QA Compliance Manager back-up resource.

JANSSEN PHARMACEUTICALS, GURABO, PUERTO RICO 11/2011 – 11/2013 Senior QA Compliance Specialist: Contributor to the site internal audit program to assure compliance with GMP’s guidelines and regulations. Support Corporate, DEA, FDA, EMEA and other regulatory agencies inspections by performing audit readiness and execution activities. Maintain NDA submissions-related documentation up to date. Review and approve GMP documentation. Support in regulatory commitments, filings, and submissions. Maintain multi-site regulatory licenses up to date. PFIZER PHARMACEUTICALS, Vega Baja, Puerto Rico 06/2007 – 11/2011 Quality Engineer (Contract Position): Perform, lead and approved investigations related to manufacturing, packaging, and laboratory deviations. Interact with management and non-local site leaders in Corrective Action and Preventive Action (CAPA) implementation and effectiveness verification activities. Resolution of manufacturing/packaging on-the-floor issues, QA triage member. QA review of

“out-of-control” process parameters events. Provide support to facility/engineering areas with calibration and maintenance activities deviations. Provide support during FDA and regulatory agencies inspections. AMGEN MANUFACTURING LIMITED, Juncos, Puerto Rico 2006 – 2007 Quality Assurance Specialist II: Responsible for on-time lot compilation and lot disposition of bulk (drug substance) product supply schedule. Initiate, revise and approve manufacturing procedures. Provide decision-making support related to manufacturing/packaging situations and initiate or approve investigations involving product quality. Conduct internal quality audits in manufacturing areas and manufacturing processes. Review and approval of process and Computer Validation Reports. Provide support for new product Introduction documentation review and approval. Experience with Support FDA, EMEA and regulatory agencies inspections. PFIZER PHARMACEUTICALS, Vega Baja, Puerto Rico 1988 – 2006 Quality Engineer (2005-2006): Development and presentation of Annual Product Records Review (APRR) to site management. Lead customer's complaints investigations from initial evaluation to root cause identification and CAPA implementation. Manufacturing quality data statistical analysis and trending for Key Performance Parameters affecting Critical Quality Attributes. Support FDA and other regulatory agencies audits and audit readiness activities. Provide quality support of manufacturing/packaging on the floor issues.

Team Leader Quality Operations/Documentation Supervisor (1998-2005): Responsible for the accurate and timely issuance of manufacturing/packaging and laboratory documentation according to manufacturing schedule priorities. Coordinate the initiation, revision and approval of SOPs and Change Control. Monitor and control of personnel training records. Participate In the internal audit, inspection readiness, provide support during FDA, EMEA and other regulatory agencies. Elsa I. Cruz, Resume

Elsa I Cruz

Senior Regulatory Compliance Coordinator (1995-1998): Responsible for periodic internal compliance audits of manufacturing processes, laboratory and procedures. Ensure Raw Materials and Packaging components compliance with regulatory requirements for different countries and corresponding Pharmacopeia. Ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture.

Quality Specialist (1990-1995): Manufacturing Batch Records and Quality documentation review and approval. Validation reports review and approval. Administer Quality Assurance Training Programs to site specific staff and new hire personnel. Conduct cross-functional investigations for manufacturing and packaging process deviations. Support to the manufacturing group in nonconformance investigations and CAPA definition and implementation. Perform and lead investigations related to manufacturing/ packaging and laboratory deviations. Participate in internal audit/inspections. EARLIER EXPERIENCE

● Microbiology Laboratory, Sr. Analyst - Pfizer Pharmaceutical, Vega Baja, PR

● Senior Medical Technologist - Clinical Laboratory Hyde Park, San Juan, PR EDUCATION

Master Business Administration (MBA), INTERAMERICAN UNIVERSITY – San Juan, Puerto Rico

● Concentration in Industrial Management and Human Resources Certificate in Medical Technologist, INTERAMERICAN UNIVERSITY – San Juan, Puerto Rico

● Puerto Rico - License # 2792

● American Society of Clinical Pathologist (ASCP) Registration - License # 1672 Bachelor of Science (BS), Concentration in Biology, Minor in Chemistry, UNIVERSITY OF PUERTO RICO - Rio Piedras Campus- San Juan Elsa I. Cruz, Resume

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