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Quality And Compliance Contracted Consultant Resume

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San Diego, CaliforniA

SUMMARY:

Certified quality auditor, ISO certified lead auditor and business management improvement specialist, international regulatory compliance expert, Quality Management System (QMS) consultant, Pharmacovigilance and Medical Safety Subject Matter Expert (SME), published research scientist, biotechnologist and experienced management executive with expertise in quality assurance/quality control, audits, inspections, product development/Total Product Profile (TPP) establishment, manufacturing, laboratory, preclinical and clinical trials, regulatory submissions, product chemistry, investigational product management, chemical characterization, formulation development, in - vivo and in-vitro studies, molecular biology, environmental monitoring, remediation, recalls, vendor and third party management, with an emphasis in developing and overseeing critical path initiatives and overall process and product control strategies in regulated ISO, CAP, CLIA, GLP, GCP, GMP and cGMP environments.

EMPLOYMENT:

Confidential, San Diego, California

Quality and Compliance Contracted Consultant

Responsibilities:

  • Conduct consulting services for start-up early phase oncology pharmaceutical firm
  • Conduct product development, critical path establishment, regulatory affairs expertise and coordination between agencies, sites and vendors for phase I-II operations
  • Conduct Investigations and Audits of clinical, manufacturing and quality incidents
  • Oversaw Vendor Management Program and Established Companies QMS policies, procedures, manuals, forms and systems
  • Conducted training to selected internal and external staff
  • Hosted investigator meetings and assisted in provided quality and compliance management for phase I and Phase IIB studies for two oncological product lines
  • Conducted root cause investigation and remediation operations in executive management capacity and executive quality representative in response to clinical trial adverse events and quality incidents
  • Suggested regulatory course of action and liaison between organization and agencies for clinical hold remediation strategies, pipeline and overall revision of previous pharmaceutical development pathways
  • Interacted and approved quality related documents related to responding to agency requests, manufacturing modifications (CMC) IND Amendment and resultant protocol and study design implications
  • Qualified CRO, CMO, and other affiliate vendors via site qualification audit
  • Subject Matter Expert in PK and statistical PV design in regards to endpoint determinations and safety evaluations of API and IP
  • Established risk mitigation strategies and investigated sources of risk to clinical trial conduct, compliance and business financials
  • Executive representative accompanying CEO and VP on meetings with vendors and other affiliates that impact the sponsors business and relative state of regulatory compliance, including specific focus to clinical hold release mechanisms and the companies re-entrance into trial
  • Reviewed all protocols in a quality capacity and identified GCP and clinical trial developmental critical path for licensed product in non-clinical, pre-clinical and entrance in to clinical phase I assays
  • Established electronic Trial Master File indexes and oversaw document/data migration activities in accordance with ICH E6 (R2)
  • Oversaw Quality Management System (QMS) development and deployment including but not limited to developing Quality Manuals, Standard Operating Procedures (SOP), and training mechanisms for internal and externally contracted staff and vendors
  • Conducted national and international vendor, site, and product audits as lead auditor and senior corporate quality representative
  • Evaluated safety signals and assisted medical monitoring in the reporting of safety related events, including but not limited to SAEs, SUSARs, etc.
  • Reviewed clinical trial documents, including investigator’s brochures, protocols, Case Report Forms (CRF), Signed Agreements, IRB/IEC documents, Laboratory procedures/tests, IP management documentation, monitoring reports, etc. and provided guidance for the remediation of any findings resultant of said review
  • Hosted Investigators Meetings and supported Investigator Sites in entrance and closure of clinical trials
  • Quality representative liaison for Clinical Safety Data Management Committee
  • Conducted Quality Control/Quality Assurance activities for reported outcomes related to agency annual reporting

Confidential, Deerfield, Illinois

Senior Quality Auditor

Responsibilities:

  • Planed, conducted, reported, and documented GxP audits on behalf of clients either in a sole, lead, or co - auditor capacity
  • Quality Subject Matter Expert for medical monitoring, pharmacovigilance, biostatistics, document management, and data management departments
  • Conducted internal audits, established or assisted in establishing Key Performance Indicators from both a departmental and program specific arena, and developed/implemented risk based processes and metrics for regulated clinical operations
  • Oversaw Corrective and Preventative Action (CAPA) program and supported remediation activities resultant of internal, external and program specific audit findings
  • Maintained GxP knowledge and expertise relevant to applicable local and international regulations
  • Supported business development and interacted with clients during bid defense and review processes
  • Hosted client and regulatory audits with track record of no adverse observational findings
  • Performed internal and external vendor management activities including revision and optimization of vendor management systems
  • Developed qualification, validation and other regulatory protocols, clinical study reports, plans, and/or documents, including amendments to such
  • Executed validation activities and provisioned Quality By Design (QbD) expertise as a Subject Matter Expert (SME)
  • Assisted in developing and documenting client regulatory submission binders and developing overall critical paths for medical device, pharmaceutical and combinational products at various stages in the product lifecycle (Discovery, Pre - Clinical, Clinical Phase I-IV and Post-Marketing Surveillance Studies)
  • Assisted in establishing client Total Product Profiles (TPP) as a scientific and quality SME
  • Developed and optimized internal and external Quality Management Systems (QMS) including the generation of Standard Operating Procedures, Work Instructions, Policies, Quality Manuals, Document Control and Management Systems (paper and electronic), Integration from paper to electronic systems (including all validation activities and establish necessary configuration control and management operations in accordance with HIPPA, the sun-shine Act and national and international regulatory statutes, standards and guidance s
  • Hosted and Acted as liaison and direct interface for internal client audits, external vendor audits and internal/external regulatory agency inspections worldwide resulting in no critical or official agency actions
  • Pharmacovigilance, Pharmacokinetic expert, auditor and regulatory compliance consultant
  • Statistical analysis expert conducting both internal and external (client or sponsor) developmental operations, consulting services, plan development, verification, reconciliation, drug substance and drug product safety and efficacy determinations for clinical study reporting, agency notification, handling of data from screen failed and/or withdrawn subjects along with endpoint conclusions for Phase I-III studies and interacted with agency, on behalf of sponsors, for entrance into the various phases, study design development, and submission (NDA, ANDA, De Novo, 510(k), PMA, CLIA Waiver, CLIA, IDE, IND, CE).
  • Conducted site, vendor, sponsor, site, CMO, CRO, Partner, affiliate, documentation audits, gap assessments, storyboards (legacy, licensing, transfer to another entity sponsor, PAI, for-cause, chronological, incident/quality investigation) /monitoring reports/IRB/IEC documentation/ (TMF/DMF/DHR/EDC/CSR/Protocol/Plan/Other Auditor Reports/Validation/Vendor Qualification/Essential Documents/Laboratory Assays/Personnel Qualification/CMC/Incident Notifications/OOS/Complaint Reports/Vendor Contracts and Quality Agreements/Proposal and Contracts/Phase I-III sponsor, sponsor-investigator, investigator, sponsor-monitor, CRO outsourced and Data management internal/outsourced/transferred, internal and sponsor owned QMS/Submission Packages).
  • GxP audits for both large and small sponsor organizations in a lead auditor and program lead capacity nationally and internationally in accordance to the applicable local, national, and internal regulations, standard and guidance s for pharmaceutical, biotech, medical device and combinational product lines for a variety of disease indications s and clients in multi-center, multi-national trials as various stages in the product development pipeline.
  • Expert SME for Chemistry, Manufacturing and Control services
  • Expert SME for Medical Device and Design Control services
  • Provided other consulting services to clients as assigned including but is not limited to remediation, Inspection Readiness Training, Story Boarding, Incident Investigation and Remediation, Site Audits, Inspections and Ongoing Monitoring of Trial operations in accordance with ICH GCP E6(R1) and ICH GCP E6(R2).
  • Developed, Implemented, Executed and Maintained Internal Training Programs and Quality Management System elements, including development and deployment of Standard Operating Procedures (SOP) and related corporate policies in both paper and electronic Systems
  • Maintained GxP knowledge and expertise relevant to applicable local and international regulations
  • Provided internal and external training on GxP, QMS, and internal regulatory standards/guidance s
  • Executed overall program and project management for internal and contracted services
  • Conducted mock and Pre-Approval Inspections (PAI) internally and externally for contracted services
  • Ensured departmental financial goals were exceeded by maintaining a 98% billable rate, cross-selling services, and performing both internal and external, client related, projects, concomitantly
  • Conducted Internal and external assessments and audits for pharmacovigilance, clinical operation, data management, regulatory affairs, contracts and proposals, quality assurance, quality control, human resource, biometrics, biostatistics, medical monitoring, clinical monitoring, medical writing, statistics, operations, OSHA, EHRM, functional service provider, validation, information technology, computer system validation, GCP, GMP, cGMP, GLP, ICH, WHO, IATA, DEA, DOT, PMRA, JMAFF, Health Canada, MHRA, EU, UK Conducted GCP site audits and other consulting services internationally for a variety of clients under the following agency/country: FDA/US, MHRA/UK, PMDA/Japan, Sweden Medical Products Agency, Denmark Health and Medicines Authority, Germany/BfArM, Czech Republic SUKL, Italy AIFA, ANSM/France, DAAAP, Heath Canada, Dutch Authority/The Netherlands).Planed, conducted, reported, and documented GxP audits on behalf of clients either in a sole or lead auditor capacity
  • Supported business development and interacted with clients during bid defense and review processes
  • Hosted client and regulatory audits with track record of no adverse observational findings
  • Performed internal and external vendor management activities including revision and optimization of vendor management systems
  • Developed qualification, validation and other regulatory protocols, reports, and/or documents
  • Executed validation activities and provisioned Quality By Design (QbD) expertise as a Subject Matter Expert (SME)
  • Assisted in developing and documenting client regulatory submission binders and developing overall critical paths for medical device, pharmaceutical and combinational products at various stages in the product lifecycle (Discovery, Pre - Clinical, Clinical Phase I-IV and Post-Marketing Surveillance Studies)
  • Assisted in establishing client Total Product Profiles (TPP) as a scientific and quality SME
  • Supported other auditors and applicable staff by reviewing/editing client deliverables and internal documents
  • Provided internal and external training on GxP, QMS, and internal regulatory standards/guidance s
  • Executed overall program and project management for internal and contracted services
  • Provided direction to staff temporarily assigned to consulting service project or departmental initiatives
  • Conducted mock and Pre-Approval Inspections (PAI) internally and externally for contracted services
  • Performed or assisted with any other tasks, programs, initiative, or assessments as assigned by Compliance and Quality management or applicable executives

Confidential, Carrollton, TX

Quality Assurance Manager

Responsibilities:

  • Developed, implemented, managed, audited and maintained GxP and ISO quality systems to support commercial and developmental activities parent product manufacturer and affiliate laboratory.
  • Coordinated and performed all vendor qualification and compliance audits.
  • Established product development program, quality management system, documentation management system, system suitability assessments, GAP analysis, personnel training and qualification systems, verification and validation systems as well as manufacturer first article (RUO, IUO, 510(k)) product specification operations including lot release activities and associated lot file compliance review.
  • Executive management oversight for all operations and quality activities performed by contract testing laboratories and contract manufacturer companies.
  • Developed, implemented, validated, managed and maintained a GXP/cGMP/ISO compliant document/data control systems including cloud based document management and Laboratory Information Management System (LIMS) 21 CFR 11; DQ, IQ, OQ, PQ .
  • Oversaw all investigations of all non - conformances (deviations, OOS), customer complaint resolution and chair MRBs.
  • Ensured that compliance requirements and quality standards were recognized, understood and maintained across the company.
  • Ensured in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines (21 CFR 58, 210, 211, 807, 809820, 860-868; ISO 13485; CLIA, CAP, EU CE, JPEG, JMAFF, WHO, USP, ICH, HIPPA, etc.)
  • Executive budgetary and managerial responsibility for Product Development, Quality Assurance and Quality Control.
  • Established cross-functional and multi-disciplinary teams and operations (e.g. manufacturing, clinical, R&D, etc.) to develop strategic operations, ensure business continuity and ensure the effective and efficient execution of predetermined project management deliverables.
  • Ensured corporate and affiliate operations maintained state of control by successfully implementing a corporate culture of compliance that included but was not limited to ongoing company quality awareness training.
  • Successfully passed all inspections by certifying and regulatory bodies.
  • Consistently maintained knowledge of current industry standards, trends and changes to quality regulations and guidelines including advising my executive management team of any business impacts resultant of said trends/changes.
  • Developed, implemented, lead, managed, audited, verified and validated corporate quality system.
  • Customized design control program including elements related to scientific validity (study design, statistical analysis, analytical method validation), product realization, intellectual property (34 patents including 9 successful orphan designations for novel nucleic acid based assays and proprietary genetic IVD probes), process competency, market viability, clinical utility, and all related documentation necessary to ensure compliance, support successful 510(k) approval and extend collaborative potential for investment relationships.
  • Created all study related documentation including all pre-clinical, clinical, analytical and investigator protocols, reports, etc. for all in-house and outsourced FDA product development activities.
  • Conducted risk assessments (FMEA, CTQ), root cause analysis, CAPA, and change control/management operations to preemptively mitigate operations to allow the reduction of risk probability, severity and occurrence.
  • Executive representative and lead of all quality efforts in corporate development.
  • Established suite of documents that collectively established a comprehensive product development program (PDP) intended to meet the FDA s design control regulations set forth in 21 CFR 820.30.
  • Established regulatory critical path initiative and overall project realization lifecycle to ensure successful regulatory approval including pre submission regulatory correspondence, documents, and providing quality guidance to the corporate staff, its affiliates and associated product development projects and programs.
  • Executive QA representative for all correspondence/meetings conducted in-house or externally.
  • Oversaw 15 clinical trial sites, 6 test facilities, 1500 study patients, 4 CRO s, 2 CMO s, and approximately 250 related vendors associated with the successful obtainment of national marketing authorization of proprietary multiplex in-vitro diagnostic device 510(k) submission .

Confidential, Conroe, TX

Quality Engineer

Responsibilities:

  • Executive manager of quality engineering operations for class II medical device facility specializing in the manufacturing, packaging, sterilization and international distribution of single - use, disposable class II medical products used in cardiovascular and general surgery.
  • Oversaw production floor operations for contract supply chain services including OEM component manufacturing, kit assembly, ethylene oxide (EtO) sterilization, climate controlled warehousing and global distribution.
  • Led and managed the performance of the site s Quality System and Quality Control processes in achieving all established customer requirements and all applicable regulatory agency requirements.
  • Ensured compliance with all established Corporate Quality System procedures, collaborated with customers to establish product quality requirements and develop customer compliance strategies.
  • Liaison between the company and various governmental agencies and notified bodies to assure compliance to all quality and regulatory standards.
  • Conducted quality system maintenance, root cause analysis, failure mode and effect analysis (FMEA), environmental and health assessments, product failure investigations, statistical product/process trending and associated MDR project management, corrective and preventative action designation, mitigation, management, and closure for process/product related concerns.
  • Lead project management organizational interfacing to assure effective, efficient and compliant product process realization and transfer to production operations per device specifications, drawings, user requirements and required compliance mechanisms as delineated per national/international regulations including but not limited to FDA GCP, cGMP (21CFR11), GMP (21CFR820), ISO-9001, ISO-13485, API, USP, GDP, ASTM, NIST, ASME, JPEG, EU, ICH, PMRA.
  • Conducted audits, close-out of audit findings, created audit finding reports and determined proper corrective and preventative actions to respond to out of specification results, customer complaints, and regulatory compliance.
  • Designed, implemented and validated process/product specifications (DQ, IQ, OQ, PQ), QC inspection processes and QA procedures.
  • Lead supplier qualification activities, audited/inspected outsourced operations, managed supplier performance and validated product processing operations.

Confidential, Houston, TX

Quality Engineer

Responsibilities:

  • Contract quality engineer for class II international medical device manufacturer.
  • Designed and installed quality control process sampling systems, procedures and statistical techniques.
  • Designed or specified inspection and testing mechanisms and equipment.
  • Formulated or assisted in formulating quality control policies and procedures.
  • Developed the economics of any quality control program as required
  • Conducted quality system maintenance, root cause analysis and lead corrective action management for process related concerns.
  • Assisted quality personnel in establishing, implementing and maintaining the quality management system.
  • Interfaced with engineering and operations to ensure manufacturing actions were in accordance with approved data and specifications.
  • Supported quality inspectors to ensure that products and processes comply with relevant requirements of the quality management system.
  • Conducted audits, close - out of audit findings, created audit finding reports and determined proper corrective and preventative actions.
  • Analyzed failure, corrective, and preventative actions to respond to out of specification results, customer complaints, and regulatory compliance including failure mode and effect analysis, root cause analysis, risk analysis and statistical analysis.
  • Continuously improved QA receiving inspection process and procedures.
  • Ensured timely resolution of supplier failure, corrective actions and preventative actions.
  • Managed supplier s performance and conducted audits.
  • Applied lean project management and quality assurance/control strategies per cGMP (21CFR11), GMP (21CFR210, 211, 820), ISO 9001, API, USP, GDP, ASTM, NIST, ASME, as well as international regulatory bodies, agencies, standards and guidance s (JPEG, EU, ICH).
  • Analyzed production and manufacturing limitations and standards and recommended revision of specifications when indicated.

Confidential, Sugar Land, TX

Quality Assurance Auditor

Responsibilities:

  • Responsible for planning, organizing and managing the overall activities of receiving/outgoing quality functions.
  • Assured regulatory compliance to Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) by auditing studies, reviewing/writing protocols, reviewing/writing Standard Operating Procedures (SOPs), reviewing/writing master schedule/file documentation, advising study directors, and interacting with sponsors and regulatory agencies.
  • Carried out report and data audits, facility inspections, in - process study inspections and protocol reviews for compliance with Good Laboratory/Clinical Practices (EPA, FDA, OECD, and Japanese MAFF), National Pollutant Discharge Elimination System (NPDES) under the Clean Water Act, Texas Pollutant Discharge Elimination System (TPDES), Resource Conservation and Recovery Act (RCRA), Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), International regulations for EU, OSPAR, and PMRA.
  • Designed and/or specified inspection and testing mechanisms, qualifications, analytical methods and measurement management systems as well equipment validation procedures, processes and data acquisition/documents (DQ, IQ, OQ, PQ).
  • Conducted protocol reviews, in-life inspections, for-cause inspections, data and report audits, and facility inspections, including generating audit/inspection reports and close-out of findings.
  • Created and maintained company quality documentation such as quality manuals, quality procedures, etc.
  • Lead continual improvement activities to enhance the quality system utilizing 5S and Kaizen lean methods.
  • Developed and conducted training for environmental health and safety and quality regulations to build ongoing quality awareness.
  • Maintained access database system for tracking of studies, related materials and documentation.

Confidential, Houston, TX

QA Director - Consultant

Responsibilities:

  • Analyzed the quality attributes of regulated class II medical devices, their reflection of product safety and efficacy, and the role of quality assurance in maintaining compliance with their stated specifications in a clinical trial and clinical manufacturing environment.
  • Examined the role of risk management in the quality environment and prepare risk analysts of processes and products towards the mitigation of significant risks.
  • Compared and contrasted the need for continuous improvement and its attendant changes with the requirement for integrity of product design, efficacy, and safety characteristics.
  • Completed one year project in six months by successfully evaluating the means by which quality by design is implemented with respect to controlling discriminate inputs with resultant outputs.
  • Differentiated between corrective and preventative action and their role in rectifying the unexpected outcomes.
  • Provided assessment of organizational maintenance of a state of control, both internally and through external vendors, via audit practices.
  • Developed and implemented logistical process/product operations with proven track record of optimization, quality, compliance, and fiscal responsibility.

Confidential, Houston, TX

Research Scientist and Study Director

Responsibilities:

  • Conducted clinical research, managed assays, projects, personnel and facilities for Confidential.
  • Developed, wrote, implemented, and validated standard operating procedures and equipment.
  • Analyzed and prepared budgets, reports, and bi-annual assessments of laboratory facilities and processes and maintained master schedules and files.
  • Provided safety, regulatory and technical training for laboratory personnel.
  • Researched cardiovascular tissue response and conditioning trends in disease and normal populations as a function of translational bio-mechanics, pharmacological response, and cellular expression systems.
  • Conducted GCP assays to evaluate pharmaceutical administration, distribution, metabolism, and excretion (ADME) of current first line therapeutics in animal model of Marfan Syndrome.
  • Audited historical proteomics, genomics, biological mechanics, signaling pathology, adverse effects and pharmaceutical compliance to GMP and cGMP regulations.
  • Developed and published analysis on multifunctional bio-composites of chitosan reinforced with carbon nanostructures.

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