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Quality Systems Management Resume

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San Francisco, CaliforniA

SUMMARY:

  • Energetic & goal - oriented professional with demonstrated success in accurate regulatory interpretation of government, NGO and institutional directives and guidance.
  • I possess the ability to effectively communicate and meet complex reporting requirements.
  • My interest in science, technology, & innovation along with a strong understanding of various market drivers and the emerging global markets in today’s world of globalization; gives me the ability to fine tune and respectfully adhere to a diverse cultural audience of participants.
  • Quality, Compliance, & Regulatory: SME of FDA regulations, ISO 13485:2016, CMDR, Medical Device Directive Regulation (93/42/EEC, 2012 Provisions) and other national and international regulations and standards related to Pharma GLP, GMP, ICH, GCP, IRB, DoH, “Common Rule,” Clinical Trials Design and Management.
  • Experience with direct contact of ISO Notified Bodies. Knowledge of change control, auditing, & Doc. Management Systems. Experienced in organizational, management & communication skills through Project Management Experience (i.e., DHR, ISO RECERT & Corrective Action, Pricing & Raw material sourcing for NPD). Thorough understanding of GMP/GDP/QMS 21 CFR:820, 820.22 practices, procedures, documentation systems, specifications, document control methodology, life cycle design and development, material traceability, concepts & workflow in a medical device, pharmaceuticals, and personal care manufacturing environment. Familiar with ECO procedures & workflows utilizing Agile. Excellent track record of maintaining high quality assurance standards. Familiarity with FDA Risk Management for Medical Devices requirements that are in scope of Directive 2011/65/EU RoHS and ISO13485. Experienced & knowledgeable about ASEAN International Foreign Registration process & regulatory requirements related to personal care manufactured products. Familiar with labeling & advertising regulations and procedure to obtain COLA for alcoholic beverages as regulated by the TTB.
  • Sustainability Leadership/Risk Assessment: Certified GRI Sustainability Reporter, adept in all phases of sustainability planning, analysis, & implementation. Solid command of sustainability technologies, economic research methodologies, team coordination, project management & reporting concepts. Offer additional expertise in documentation within a manufacturing/R&D environment; readily garner high levels of stakeholder engagement.
  • Accounting: Demonstrated track record of accuracy & accountability in preparing comprehensive financial report & budgets. Keen vision in structuring viable short & long term business plans; dedicated to streamlining reporting processes to control costs, eliminate waste, & ensure compliance with governing regulations.
  • Key Strengths: Thrive in challenging, fast-paced environments that require strong focus, personal tact, and exemplary team-building skills. Interests include CSR, GRI and latest trends/legislation related to research and development in the pharmaceutical and medical device industries that emphasize technology, innovation and various competitive market and global drivers; particularly in the emerging global economies.

PROFESSIONAL EXPERIENCE:

Confidential, San Francisco, California

Quality Systems Management

Responsibilities:

  • Contract Manufacturing SME
  • Analysis and Assessment of current Device Assembly process
  • Analysis and Assessment of Device sterilization options
  • Contract Manufacturing Selection and Qualification(supporting role)
  • Packaging and Label Configuration
  • Contract Laboratory Selection and Qualification
  • Contract Manufacturing Site representative (supporting role)
  • Inventory Supply Management
  • Manufacturing Lot Release
  • Quality Control testing review and disposition
  • Clinical Packaging site representative (supporting role)

Confidential, irvine, California

Business Analyst I - Change Analyst

Responsibilities:

  • Managed all aspects of the change control process to ensure proposed changes comply to defined procedure, are fully evaluated, planned, documented and implemented.
  • Ensured data integrity of each CO to assure clarity and completeness. Verified change classification.
  • Analyzed and evaluated supporting documentation to ensure that each change is effective.
  • Provided technical direction and consultation to technical support staff or other organizations.
  • Developed metrics to evaluate the effectiveness and efficiency of the process.
  • Scheduled the Change Control Board meetings and prepared the agenda.
  • Chair CCB meetings and confirm team consensus, resolve outstanding issues
  • Promoted configuration management principles and trained others on its importance.
  • Promoted good documentation practices and proper management of data and records.
  • Provided the Product Development Team with avenues for candid feedback on product change control processes, non-conformance processes and tools.
  • Designed and recommended improvements to team processes, procedures and tools.
  • Designed and recommended process improvement to achieve system metrics.

Confidential, san diego, California

Quality Management Systems

Responsibilities:

  • Project Management of ISO Recertification working cross functionally within company, Notified Body and SMEs to meet deadline utilizing tele-con as necessary.
  • Authored documents, Risk Management SOP, tools, matrix, FMEA, Hazards Analysis, and Risk Management Plan. Researched, assisted and streamlined in response to ISO Stage 2 audit nonconformance (Project Management cross functionally): Clinical Evaluation Report, Technical Construction File, Literature Protocol, Post Market Surveillance and Data Analysis (Pharmacovigilance) to be in compliance of the Essential Requirements Checklist: MDD European Council Directive 93/42/EEC.
  • Created and managed all processes related to QA Document Control.
  • Managed tracking database for all Quality System records.
  • Acted as a liaison between other departments and QA to help integrate and implement quality systems throughout company.
  • Participated in QA meetings to inform upper management of quality issues discovered, contribute to creating resolution and upon decision made by upper management, ensuring that outcome is properly tracked in the quality system documentation.
  • Documents: assign, track and archive all documents in each controlled document category (agreements, bill of materials, drawings, labeling, packaging, inserts, and finished goods, master batch records, policies, specifications, protocols, reports, SOPs, and website pages).
  • Document Change Requests (DCRs): assigned, tracked, processed and archived DCR with completed document; maintain all records current and history, electronically and hardcopy and maintain tracking database to allow for variety of reporting capabilities.
  • Routed DCRs to all reviewers/approvers for various review stages; maintain control over required signatures and integrity of the document source.
  • Initiated/authored CAPAs when required upon discovery of quality issue.
  • Entered records into tracking database and file accordingly; maintain individual employee’s collection of training records.

Confidential, Carlsbad, California

Document Control Clerk

Responsibilities:

  • Verified RoHS compliance for critical care ventilator bill of material, accessories, and options for over 3500 parts. Attached appropriate documentation to all parts within Agile.
  • Processed Engineering Change Orders (ECOs) for Critical Care Ventilator though Agile as requested by supervisor.
  • Served as supporting staff within corporate audit. Helped address non-conformances by providing objective evidence for corrective and preventative actions.
  • Earned ISOS Group certification in GRI Sustainability Reporting (GRI3), demonstrating deep knowledge of GRI framework, materiality and indicator selection, stakeholder identification, and of the complete sustainability reporting cycle.
  • Successfully coordinated, led, and executed collaborative 2011 strategic and business development consultation project for Revolution Landscape

Confidential, San Diego, California

Document Control Coordinator

Responsibilities:

  • Audited control document binders for accuracy and completeness; updated cGMP employee signature records.
  • Reviewed and processed change requests from document authors; collaborated with authors to ensure correct formation and referencing prior to implementation.
  • Worked closely with production personnel to guarantee scheduling and ability to meet ship date requirements (JIT); trained and tracked staff across diverse departments in ASEAN registration process.
  • Successfully project-managed new product development, with scope of responsibility including sourcing of raw materials, pricing, scheduling, customer sample submissions, and documentation.
  • Liaised effectively across Business Development, Sales, Customer Service, Production, and R&D divisions to ensure FDA compliance of all product lines prior to launch.
  • Designed and implemented efficient new processes for new customer on-boarding.

Confidential, San Diego, California

Accounts Payable Specialist

Responsibilities:

  • Optimized accounts payable processes. Processed 100+ invoices each day, administered 300 vendor accounts, and released weekly checks of 250K+ to 30+ vendors; prepared receipt of goods for purchase orders.
  • Analyzed and posted employee expense accounts; processed customer applications for credit accounts.
  • Accurately balanced general ledger against inventory account. Initiated small claims court proceedings for delinquent accounts.
  • Identified and eliminated wasteful financial practices, introducing streamlined cost controls to contribute to increased profitability.
  • Introduced lean accounting and business practices as well as defining cost-effective long-term purchasing strategies.
  • Ensured strict operational compliance with all GAAP standards.

Confidential, San Jose, California

Office Manager / Accounts Payable Specialist

Responsibilities:

  • Directed administrative staff in all office functions including business accounting, scheduling, AP/AR, and data processing.
  • Managed accounts for 200 vendors and suppliers; processed orders and coded invoices, generated on-demand checks, and tracked petty cash.
  • Utilized ADP to produce monthly payrolls for 40 employees; created Mas90 trial balances, monthly bank statement reconciliations, general ledger entries, and various financial reports.
  • Assisted external CPA in compiling data for year-end financials. Trained and mentored office team; coordinated special events.
  • Processed daily cash receipts of $25K+ and bank deposits of ~500K with 100% accuracy.
  • Ensured strict operational compliance with GAAP standards.
  • Fostered strong esprit de corps and positive teamwork among office staff.
  • Readied extensive documentation key to 2008 merger / acquisition.

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