Quality Assurance Project Management

SUMMARY OF QUALIFICATIONS

Seasoned Quality Assurance and Compliance Specialist with over 15 years of experience in Pharmaceutical and Biotechnology industries. Adept in managing and overseeing commissioning and qualification (C&Q) protocols, Change Control Processes, and ensuring compliance with cGMP standards. Demonstrated proficiency in handling Complex Project Management Tasks, Coordinating Cross-Functional Teams, and providing quality engineering consulting to support corporate and plant activities. Experienced in Root Cause Analysis, CAPA management, and the Development of Standard Operating Procedures (SOPs) and validation protocols. Known for Maintaining Meticulous Documentation, Facilitating Regulatory Inspections, and driving Continuous Improvement Initiatives. Proficient creating, reviewing and approving Quality and Manufacturing Investigations, personnel interviews, trainings, and systems review. Proven track record in Quality Assurance roles at leading companies such as Janssen, Pfizer, Amgen, and Bristol Myers Squibb with experience in Cell Therapy Manufacturing. Successfully Managed Quality Events, Investigations, and CAPA processes, ensuring timely resolution and compliance with industry regulations. Skilled in collaborating with cross-functional teams to achieve project goals, Conducting Thorough Investigations, and providing expert guidance on Quality and Compliance Matters. Experienced in supporting audits and inspections, implementing Lean Transformation initiatives, and maintaining inspection readiness. Committed to upholding the highest standards of quality and regulatory compliance, with a strong focus on data integrity and operational excellence.

PROFESSIONAL EXPERIENCE

Nov 2023 – February 2024

Janssen, Raritan, NJ

C&Q Documentation CAR-T (Onsite)

•Responsible for review and approval of Commissioning and Qualification (C&Q) protocols (for execution and executed), technical reports and associated data for conformance to regulations, SOP’s, specifications, and other applicable acceptance criteria, specifically data integrity for the cGMP Clinical and Commercial Cell Therapy Manufacturing facility in Raritan NJ.

•Documentation includes executed protocols, protocols for execution, vendor executed qualification protocols, in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.

•Project management of multiple and complex projects to comply with deliverables due dates, coordination and collaboration across relevant cross functional teams to establish a strong, compliant C&Q program to enable robust production, testing and release of product to patients.

•Provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.

•Assesses and participates in the creation, revision and review of Change Controls from the C&Q perspective.

May 2021- Jun 2023

Pfizer, McPherson, KS

Quality Engineer Investigator, Quality Operations (Remote)

•Act as a Corporate and plant resource to standardize investigations through process evaluation, template development and training.

•Provide quality engineering consulting (to include investigations, CAPA and training) to support Corporate and plant activities.

•Evaluate process/procedure changes as necessary and assure changes are implemented in associated plant procedures.

•Track, trend, and act on CAPA program requirements in a systematic and effective way to assure timely closure.

•Promote consistency in investigation practices across Corporate and plants.

•Review and evaluate sensitive, confidential information and develop recommendations for use by plant Quality and Corporate Quality management.

•Perform and document manufacturing investigations regarding plant issues and critical defect audit failures. This may include investigation of Production, Incoming Quality, Chemistry, Microbiology, Engineering, Validation, and other personnel necessary to complete the investigation. Conduct personnel interviews and system reviews. Act as an unbiased investigator with questions surrounding the specific issue.

•Evaluate corrective actions in regard to trends. Identify and implement preventive actions to eliminate the potential for non-conformities to occur. Perform follow-up activities to coordinate the completion of corrective and/or preventive actions. Design studies as needed to gather critical data for investigations and/or corrective actions.

•Track, on a daily basis, the progress of all assigned manufacturing investigations as they pertain to Exception Reports/Quality Assurance Reports. Report progress in the weekly department meetings and Product Flow Optimization (PFO) meetings.

•Remain current in regulatory expectations and industry practices regarding manufacturing investigations and CAPA.

•Responsible for completing manufacturing investigations in a timely manner. Independent action and sound decision making are essential for success in the position as decisions can impact product release and compliance with GMP.

•Advanced analytical skills to create and analyze potential trends.

•Decisions made based upon knowledge and experience with input from the Quality Investigations Manager or other Quality Managers as required. Work in a team-based environment with minimal supervision to direct activities.

•Provide weekly feedback to the area manager. Constant interaction with Plant personnel (management and individual contributors) to resolve investigation related issues.

•Work in interdepartmental environments focused on root cause engineering. Think and problem solve in group situations that require tight time frames. To get all the necessary data from different departments in a set time-line.

June 2020 – May 2021

Amgen, Juncos, PR

Sr QA Specialist – Validation and Change Control (Hybrid)

•Provided quality and compliance expertise & guidance and agrees on implementation strategies related to the design, installation, commissioning & qualification, and process qualification and change control of the manufacturing strategies for the existing and new facility.

•Collaborated cross functionally to ensure qualification and validation activities are implemented in accordance with established procedures and applicable regulations. Partner with other facilities in the network to ensure implementation of standard processes, consistency, and continuous improvement.

•Reviewed and approved controlled documents, including Standard Operating

Procedures, Validation Protocols, Validation Reports.

•Ensured that all activities & related documentation for comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.

•Own quality related Standard Operating Procedures, Work Instructions, Forms.

•Ensured relevant processes, equipment, system are validated and the validation is current.

•Supported and represented Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

•Supported Lean Transformation and Operational Excellence initiatives

February 2020 – April 2020

Immunomedics, Morris Plains, NJ

Microbiological Deviations Investigator (Onsite/Remote)

•Responsible of investigating microbiological deviations to support clinical/commercial Biotechnology Products.

•Responsible for working with manufacturing, laboratory, and QA teams to agree on appropriate CAPAs as needed.

•Recommend revision or creation of Standard Operating Procedures, Qualification/ Validation Protocols, Risk Assessments.

•Subject Matter Expert in quality and compliance in the biopharmaceutical industry.

•Collaborate with GxP Subject Matter Experts to write, review, or edit technical GxP documents in a clear, concise format.

•Meet key timing commitments, with well-investigated and well-documented reports.

•Coordinate and follow-up with personnel/department managers where the event occurred to gather additional information, facts, documents and applicable data.

•Utilize root cause analysis techniques during the deviation investigation process and perform prompt and thorough investigation in compliance with associated regulatory requirements.

•Determine scope, root cause, and product impact of the event, appropriate CAPA plans to address identified deficiencies, or prevent reoccurrences and potential nonconformances.

•Assist the Data Integrity Governance Committee in DI investigations.

•Assist in the retrieval and compilation of quality metric data for the investigative process.

•Assist Quality Compliance management maintain a state of inspection readiness and compliance with 21CFR, ICH Q10, EU GDP/GMP.

April 2019 – December 2019

Pfizer, Mc Pherson, KS

Biological Quality Investigations Engineer (Remediation Project) (Onsite)

February 2014-February 2019

CIS, LLC, Medial Group, ARGON, LLC

Business Development and Operations (Hybrid)

•High – end Consulting Services include: Business Strategies and Customer Relations, Business Development, Organizational Culture Transformation.

NEOLPHARMA (CEDIPROF), Caguas, PR

Sr. QA Consultant (Product Development) - May 2013 to December 2013

•Worked with cross-functional teams for the revision, creation and alignment of SOP’s and Forms to include regulatory requirements for the manufacturing of new Controlled Product Schedule II and PD operations.

•Performed assessments and provided quality and compliance consulting for the documentation requirements for new Controlled Product Schedule II.

•Responsible for the technical writing according to company quality standards.

•Creation, revision, consolidation and approval of SOP’s using the PDOCS system.

BRISTOL MYERS SQUIBB, Humacao, PR

Project Manager / Compliance Specialist - September 2011 to December 2012

•Identified resources needed and worked with all agency functions to assign individual responsibilities.

•Created and executed project work plans and timelines and revised as appropriate to meet changing needs and requirements.

•Managed day-to-day operational aspects of a project and scope.

•Open jobs/created change orders in software system.

•Lead project scoping.

•Effectively communicates relevant project information to functional teams.

•Worked with production to create appropriate production schedules.

•Facilitates team and client meetings to review work and provide status.

•Prepared regular status reports and distributes internally and externally as necessary.

•Held regular status meeting with project team.

•Reviewed deliverables prepared by team before presenting to client. • Resolved and /or escalates issues in a timely fashion

•Managed both internal and external approvals.

•Monitored scope creep and re-scopes projects as necessary without affecting timelines.

•Assures project legal documents (photo releases, property releases, etc.) are completed and signed.

Responsible of the coordination of Regulatory Agencies Inspections Readiness, participate as Audit Team Member, Support during Site Audits and Inspections

(Corporate, FDA, EMHA, PMDA, EMA, Business Partners)

•Responsible to conduct Site Internal Audits

•Responsible to provide documentation for Product filings for new markets

•Supports all site Initiatives and any other assignments based on business needs.

•Responsible of the stability of all products manufactured and tested at the Site

•Change Controls, Investigations and CAPA Management of all stability related quality events.

•Responsible of the transfer of the Examination for defects from the QC Lab to the manufacturing areas and accountable of the operators qualification.

•Coordinate Trackwise New Workflow implementation activities which includes not limited to: project status meetings, scheduling, supporting the revision of SOP’s and related documentation, training. Global initiative.

•Revision of impacted documentation by new TW module such as SOP’s, forms, training on new revisions.

•Responsible for the revision of SOP’s due to implementation of new module in SAP for the Heightened Sampling Process

•Annual Product Quality Reviews

•Extensive audit experience

PFIZER, Guayama, PR

Lead Investigator/CAPA Expert/SME- July 2011 to September 2011

•Executes and ensures that all Quality Events (QEs), Notice Of Events (NOEs) and CAPAs are completed/closed within the established timeframe, utilizing the right tools to measure effectiveness to prevent reoccurrence.

•Monitors and assures that action plans have been implemented.

•Reviews and provides input to regulatory submissions applicable to area of responsibility.

•Interacts with regulatory compliance agencies with respect to Quality Events.

•Leads QE's and CAPA's trend evaluation.

•Conducts systematic QEs evaluations to minimize risk of reoccurrence and; ensures the effectiveness of CAPA's.

•Supports establishment of process monitoring parameters and controls limits.

•Evaluates and revises manufacturing documentation resulting from a compliance gap and; may assist in providing training related to the revised manufacturing documentation.

•Creates awareness of trends and addresses situations with the affected area.

•Participates and represents the manufacturing department in all process compliance initiatives.

•Performs as the key contact during regulatory inspections.

AMGEN MANUFACTURING LIMITED, Juncos, PR

Plant Quality Assurance Specialist, November 2010 to July 2011

•Thorough exposition of new product introduction activities.

•Clinical and validation batches evaluation.

•Ensure document control and regulatory compliance

•Support the Solid Dosage Manufacturing Operations from PQA perspective including: Weighing and Dispensing, Granulation, Final blend, Compression, and Coating

•Support the Plant Quality System Unit for AML023 including Non-Conformances, Corrective and Preventive Action Management, Process Validation, Trend Analysis, Internal Audits, Batch Record Review, other related duties.

•Revised and approved investigations; monitored and analyzed process trends; and prepared reports for quality systems such as Trend Reports and support the Annual Product Review

•Performed GAP Analysis and internal audits regarding executed Manufacturing Procedures for Stability Batches, Validation Batches and GMP Batches that will be part of the submission for new product

•Performed GAP analysis to CAPA’s system and Visual Inspections performed during different stages of manufacturing process as part of the PAI readiness initiative

•Designed a GMP checklist for Pre-approval inspection readiness and regulatory agencies visits readiness

•Participated during site audits including Mock Inspections, FDA and MHRA audits.

EDUCATION

MBA in Global Management

UNIVERSITY OF PHOENIX, Guaynabo, PR

BS in Biology Minor in Chemistry

UNIVERSITY OF PUERTO RICO, Cayey, PR

LICENSES & CERTIFICATIONS

•Executive and Sales Mastery Coaching, The Growth Coach Business and Sales Coaching

•Investigation and CAPA Auditor

•Certified Quality Auditor (Training)

•Six Sigma Yellow belt

COMPUTER SKILLS

Windows: MS Office (Word, Excel, Power Point), Access, Fieldglass, SAP, TrackWise, DMS, DCA, PDOCS, Empower-AS400, Temptale software, Maximo, Kneat.

Contact this candidate