SUMMARY:

Innovative Quality Assurance Compliance Specialist and ASQ Certified Quality Auditor with experience in cGMP regulated environments. Consistently applies Operational Excellence (OpEx) techniques in all assigned projects. Pro - active, creative problem solver who systematically seeks to improve operations and work smart. Excellent analytical and teamwork skills to achieve organizational objectives. Bilingual (English & Spanish).

TECHNICAL SKILLS:

Software: Sample Manager LIMS, Trackwise, MS Office, MS Project, MS Visio, SAP

Skills and Proficiencies: GxP/GMP/GLP/GDP Investigations/Root Cause Analysis Presentations/Briefings Lean Manufacturing Internal/External Auditing Sampling Process Mapping 5S / Visual Metrics Process Development Updating QC/ Mfg. SOPs / Technical Writing Inventory Management Validation Review Manufacturing/Engineering Support Change Control Review Batch Record Review Corrective/Preventive Actions Work Order Review

PROFESSIONAL EXPERIENCE:

Confidential, Boca Raton, FL

Supplier Quality Assurance

Responsibilities:

• Managed suppliers and vendors approvals and notifications, product complaints, and internal audit program.
• Supported manufacturing activities performing in-process batch record reviews, release of raw materials, deviation investigation, QC assay oversight and plasma look-back investigations.
• Supported Document Control process improvement activities for inspection preparedness.
• Lead auditor in internal audits to review and improve the organization’s QS.
• Maintained detailed and updated list of qualified vendors, audit results, and classifications.
• Managed product complaints to assess criticality.
• Performed PQ test scripts to qualify internal/external audit processing in SoftExpert eDMS.

QA Specialist

Confidential

Responsibilities:

• Developed new work instructions and SOPs to facilitate the training of new hires in QA and Manufacturing areas.
• Initiated program of daily operations walkthroughs of Manufacturing areas to assure quality compliance.
• Performed real time batch record review.
• Performed material disposition for components, raw materials, and in-process material using LIMS and SAP.
• Conducted investigations of deviations to determine their quality impact and implement CAPA.

Confidential, Gainesville, FL

QA Specialist

Responsibilities:

• Bolstered QA activities in gene therapy research start-up by building quality systems, auditing vendors and reviewing GLP studies, laboratory notebooks and manufactured material to be used in clinical studies to ensure regulatory compliance.
• Authored several core quality compliance SOPs that strengthened the organization’s quality system.
• Developed a Good Documentation Practices training program for associates and new hires.
• Audited and reviewed GLP toxicology study and IND submission to the FDA.
• Audited CROs and CMOs.
• Performed scheduled internal audits.
• Performed batch record reviews manufactured by CMOs.
• Developed inventory system to track CTMs and cGMP materials.
• Conducted investigations of deviations to determine their quality impact and implement CAPA.

Confidential, Sunrise, FL

QA Document Specialist

Responsibilities:

• Supported Production and QA activities by providing logbooks, document numbers and/or data to ensure regulatory compliance and efficient operations.
• Destroyed batch records past retention period.
• Optimized five different process workflows resulting in ~20% time savings in procedure deliverables.
• Implemented Visual Management project to improve logbook issuance to less than 5 days’ dispatch.
• Developed SOP for destruction of past retention batch records, destroying over 2500 boxes in third party storage in first year of implementation.

Confidential, Allston, MA

QA Compliance Specialist

Responsibilities:

• Supported manufacturing activities for in-process batch record reviews, releases/rejections, line inspections, deviation investigations and resolutions, and process improvement.
• Led team of 5 QA Specialists accomplishing release of 64 lots in 2011 to comply with stock demands.
• Reviewed batch records during consent decree; achieved 98% effectiveness under third party overview.
• Conducted investigations of deviations to determine their quality impact and implement CAPA.

Confidential, Boston, MA

QA Specialist

Responsibilities:

• Originated, reviewed, approved and distributed packaging specifications and standards.
• Sorted P&G India CSS BOMs documentation and helped the site achieve 100% in the QAKE audit.
• Built and updated BOMs increasing the department delivery of approved BOMs by 15%.

Confidential, Bedford, MA

QA Document Specialist

Responsibilities:

• Wrote and updated QC and Manufacturing SOPs.
• Supported manufacturing activities by reviewing batch records and opening and leading investigations of deviations.
• Developed a precise SOP for the calibration of oxygen sensors.
• Coordinated weekly meetings with QC, Manufacturing and Engineering Qualification supervisors to discuss document changes as well as deviations and CAPAs.

Confidential, Cambridge, MA

QA Associate

Responsibilities:

• After workforce reduction in PR, relocated to US and was selected for position at pharmaceutical manufacturer of Vivitrol used to minimize addiction withdrawals.
• Audited validation protocols, final reports, and Change Control documents and compiled observations and corrections in a database.
• Coordinated bi-weekly meetings with project managers and area supervisors to discuss Change Controls status.

Confidential, Juncos, Puerto Rico

QAL Associate

Responsibilities:

• Recruited to support large biotech manufacturing facility with 5000 Confidential producing a series of branded drugs (Epogen, Neupogen, Embrel and others).
• Utilized Sample Manager LIMS to enter data and ensure compliance on batch record review, chain of custody and shipping of samples to three domestic and one European location (sister sites or contract laboratory).
• Sampled water utilities using aseptic techniques.
• Developed and managed inventory system, saving an average of $480 per reserve sample withdrawal.
• Established inventory following specific reference standards and controls used in the QC labs.
• Performed batch record reviews of in-process material.
• Created and edited SOPs improving sample management and chain of custody processes.