SUMMARY:

• Experienced Study Director/Analytical Chemist/Quality Engineer
• Quality focused, detail oriented diversified Analytical Chemist and Supervisor with 2 year experience in FDA regulated environment.
• Proven to be skilled at learning new concepts quickly able to work under pressure, communicate ideas clearly and effectively, both verbally and in writing.
• A dynamic supervisor with excellent multi - tasking skills, experience writing SOPs, modifying SOPs and LOPs, also experienced with MDR, MEDDEV and Supplemental filings as well as CAPA remediations.
• Experienced in assuring compliance with site Quality Systems procedures and adhering to all parameters of FDA CFR 21 Part 803 and ISO-9001and ISO 13485.
• Experienced working with various regulatory agencies such as OSHA, EPA, FDA, NIOSH, ELPAT, DOD, and DEQ and possess excellent customer service skills.
• Experienced in preparing Adverse Event Reports per FDA CFR 21 part 803 for Medical Device Reporting and experienced with 21CFR 806, 21 CFR 820.198 and 820.200 for Risk Management.
• I am experienced with Process and Instrument Validations for both Medical Device and Analytical processes.
• I have experience in medical terminology and transcription. The ability to apply Quality System Regulations to SOPs, mGMPs, GMP and OSD batch processing.
• Ability to make decisions that will maximize both individuals and teams through training and positive work ethics, excellent problem solving/troubleshooting and QC skills as well as computer skills.

TECHNICAL SKILLS:

COMPUTER: MS word, MS Access, Excel, Outlook, PowerPoint, HP GC Software, TrackWise, LIMS, Master Control, WindChill, OMNIC, DocuSphere, Agile,AS400 Production, TQ Analyst (V6), Compliance Wire, MedWatch and ETQ

WORK EXPERIENCE:

Confidential, Warsaw, IN

Quality Engineer/MDR-Investigator Specialist

Responsibilities:

• Review identified materials for potential complaint information
• Enter identified complaints into complaint database
• Complete MDR Determination forms as necessary
• Create 3500a forms (i.e. MedWatch, MEDDEV)
• Conducts or assists with complaint investigations
• Review Quality data to support investigations
• Document complaint investigation results along with other required information per procedure
• Review existing complaints for appropriate MDR reportability decisions
• Augment existing complaint files with appropriate level of documentation
• Complete other documentation as necessary to ensure the complaint files stand - on- their- own .
• Discern the level of investigations required for each issue
• Utilize formal problem solving and root cause analysis tools and appropriate application of tools
• Analyze and organize data from multiple sources by utilizing statistical and data analysis tools to identify trends
• Work with Confidential s manufacturing, product development and quality engineers during the execution of complaint investigations
• Assist MDR Consultants/Clinicians (Adverse Event Specialist) with MDR s (technical)
• Prepare and submit MDRs for Domestic and International Complaints
• Complete documentation review forms per remediation protocol(s)
• Initiate complaint files in complaints database
• Document MDR Determinations
• Create 3500a s (i.e. MedWatch)
• Document complaint investigations
• Obtain or generate objective evidence to support complaint investigations
• Document complaint investigation summaries to support further investigation/no further investigation decision
• Apply CAPA s for FDA compliance of product complaints

Confidential, New Haven, CT

NHC-PMV-Closing Consultant

Responsibilities:

• Issuance of Domestic and International Field and Technical Reports by processing allegations of defective products
• Field incoming phone calls from customers and sales force
• Enter all complaint information into Quality Assurance database
• Communicate complaint information to Quality System Analyst for review and follow - up
• Enter international or domestic complaint information into the complaint database
• Communicate FTR numbers to sales representatives
• Filing of processed complaints
• Determine whether a product malfunction or serious occurred due to product malfunction/deficiency
• Review QA/QC investigation for MDR or Supplemental MDR filings
• Determine whether a product malfunction or serious injury report needs to be filed with the FDA
• Determine whether a 30 day or 5 day MDR report is required
• Generate complaint files/ records for litigation purposes
• Evaluate complaints for determining MDR/Vigilance events and document rationale for not filing MDRs
• Ability to utilize Medwatch for Adverse Events
• Maintain complaint records for MDRs
• Filing of Supplemental MDRs when required
• Closing of complaints
• Generate legal letters for follow up to collect additional information from the reporting authority
• Participate in training sessions for sales forces on products
• Demonstrate good documentation practices for operating procedures and complaint records
• Perform final review for closure of complaint files to ensure accuracy, completeness and attention to detail
• Ability to comprehend and apply Quality System Regulations and FDA regulations
• Demonstrate strong knowledge of company products
• Ability to apply components of CFR21 Part 803/806/820, ISO 135485 & MEDDEV 2.12-1
• Ability to apply SOP s to daily regulatory process and utilization of WindChill, Agile and Master Control
• Maintain required Certifications by local and federal agencies

Confidential, West Chester, PA

Analytical Chemist/Study Director

Responsibilities:

• Determine whether a product malfunction or serious occurred due to product malfunction/deficiency
• Review External/Internal Laboratory Results including Wet Chemistry reports
• Review product manufacturing scope including process and product blue prints and packaging
• Write Summary Chemistry Reports and Biocompatibility for medical device implants and Safety Hazards associated with implant based on biological and chemical laboratory results reviews
• Data analysis including gravimetric, spectra and chromatograms from various instruments
• Review toxicological results from laboratories for possible contaminants for HHE assessment
• Review packaging and production process for HHE contaminant assessment
• Product risk assessment based on product manufacturing process and product use scope and procedure
• Apply components of CFR21 Part 803/806/820, ISO 135485 & MEDDEV 2.12 - 1
• Review product packaging for Quality and product manufacturing
• Maintain product process and listings for manufacturing and packaging
• Provide updates and Quality changes to various departments including manufacturing, QA and product engineering
• Polymer Chemistry analysis and review for Biological Safety Evaluations
• Biological Safety Evaluations, Chemical Characterizations
• Process Validation, QSR Retention, Document Change Controls, Labeling, Product Developments and write deviations that address quality changes for products and required product recall
• Prepare post market final evaluation reports that address necessary deviations for product adjustments for use
• Review and provide Worse Case Scenario Exception Reports for products due to required quality assurance deviations
• Provide technical non-conformance and corrective action reports for FDA regulated industry
• Provide technical product recall based on process and labeling non conformance
• Review data and process to determine if the contamination was due to leachable contaminants from packaging, product development, validation or other contact
• Compliance with all regulatory, quality, and safety requirements as required
• Identify contaminants and unknowns from various test results including GC/MS, various digestion and analysis data including ICP/MS, wet chemistry and the review of toxicology reports
• Sterile and Non-Sterile BSE/CTP Splits
• Tech File Remediation
• WindChill, Agile, DocSphere and Master Control
• Ability to utilize Medwatch for FDA Adverse Event Reporting

Confidential, Covington, GA

Field Assurance/Post Market Specialist

Responsibilities:

• Determine whether a product malfunction or serious injury report needs to be filed with the FDA
• Determine whether a 30 day or 5 day MDR report is required
• Generate complaint files/ records for litigation purposes
• Evaluate complaints for determining MDR/Vigilance events and document rationale for not filing MDRs
• Maintain complaint records for MDRs
• Determine whether a product malfunction or serious injury report needs to be filed with the FDA
• Determine whether a 30 day or 5 day MDR report is required
• Generate complaint files/ records for litigation purposes
• Evaluate complaints for determining MDR/Vigilance events and document rationale for not filing MDRs
• Ability to utilize Medwatch for Adverse Events
• Maintain complaint records for MDRs
• Filing of Supplemental MDRs when required
• Review QA/QC investigation for MDR or Supplemental MDR filings
• Closing of complaints
• Generate legal letters for follow up to collect additional information from the patient or Attorney s
• Participate in training sessions for sales forces
• Demonstrate good documentation practices for operating procedures and complaint records
• Perform final review for closure of complaint files to ensure accuracy, completeness and attention to detail
• Experienced working with Confidential
• Ability to comprehend and apply quality system regulations and FDA regulations
• Demonstrate strong knowledge of company products for recall and re - evaluation of Risk assessments
• Ability to apply components of CFR21 Part 803, 806
• Ability to apply SOP s to daily regulatory process
• Maintain required Certifications by local and federal agencies
• Proficient in the utilization of Master Control
• Ability to utilize Medwatch for Adverse Events Reporting for FDA
• Collaborate with cross functional teams including, Engineering, Manufacturing and Management, to ensure CAPA s are addressed in accordance with FDA regulations 21 CFR 820, in a timely manner
• Perform collective analysis of CAPA s and Nonconformance for trends to ensure products are meeting specification.

Confidential, Stockton, UT

Laboratory Senior Chemist

Responsibilities:

• Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed, compiled and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
• Assist in Hazardous Waste Management including proper packaging, labeling, documentation required by DOT, EPA, OSHA and DOD for shipping to disposal sites.
• Adhere to RCRA, TSCA and CERLA regulations for proper disposal of hazardous waste.
• Analyze organic or inorganic compounds to determine chemical or physical properties, composition, structure, relationships, or reactions, using chromatography, spectroscopy, HPLC or other laboratory techniques
• Perform extractions for composition and determination of leachable compositions of chemical weapons for neutralization and destruction
• Induced changes in composition of substances by introducing heat, light, energy, or chemical catalysts for quantitative and/ or qualitative analysis
• Provided government required cradle to grave documentation on all tests and results with proper QC documentation per EPA and DoD
• Compliance with all regulatory, quality, and safety requirements
• Statistically evaluate analytical data to analyze trends and develop correlations to critical - to-quality attributes
• SOP modifications when required for proper analysis and documentation
• Validate instruments for performance standards of established parameters and LOD s
• Validate methods for SOP and LOP parameters being used for qualitative and quantitative results
• Perform required annual method and instrument validations to maintain certification levels for both qualitative and quantitative reportability and LOD s
• Maintain Secret Government Security Clearance

Confidential, Pryor, OK

Lab Analyst

Responsibilities:

• Analyzed samples for pH, color, protein content, conductivity, particle size, moisture, Rheology
• Made up calibration and working standards for analysis on LECO instrument and GC/MS and LCMS
• Utilized LECO instrument and MS for protein content and percent protein
• Prepared spikes for QC purposes on sample analysis
• Prepared standards for growth cultures in Microbiology lab
• Assisted in maintaining laboratory certifications for EPA, OSHA and FDA
• Maintain Analytical laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
• Validate instruments for performance standards of established parameters and LOD s
• Validate methods for SOP and LOP parameters being used for qualitative and quantitative results
• Implemented LIMS system for EPA regulated Production Analytical Laboratory to include sample tracking, QA/QC and client reporting with proper documentation

Confidential, Broken Arrow, OK

Inorganic/Uranium Lab Supervisor

Responsibilities:

• Method development for Inorganic laboratory instruments including GC, GC/MS, ICP/MS, GFAA
• Perform method and instrument validation for qualitative and quantitative reportability to establish and maintain LOP s, SOP s, LOD s and laboratory performance records for regulatory agencies and inorganic and uranium laboratory certification
• Analyzed samples for metals by ICP, ICP/MS, GFAA, KPA Analyzer and Hg Analyzer
• Trained laboratory technicians for sample digestion and assisted with sample digestion when needed performed annual reviews for laboratory technicians and merit increases
• Statistically evaluate analytical data to discover trends and develop correlations to critical - to-quality attributes, write technical reports and (SOP s and LOP s) prepare standards and specifications for processes, facilities, products, or tests maintained files on all analysis as well as sample digestion logs
• Responsible for department audits by EPA, DEQ, OSHA and other regulatory agencies
• Performed WP Performance testing required to maintain inorganic department certification
• Obtained laboratory certification for RCRA metals, eliminating third party laboratory analysis for metals and increased profits by 28%
• Implemented LIMS system for EPA regulated Analytical Laboratory that to included sample tracking, QA/QC, data entry, instrument maintenance, reporting and CRM for Inorganic Laboratory and Uranium testing
• Compliance with all regulatory, quality, and safety requirements

Confidential, Verdigris, OK

Sr. Laboratory Analyst

Responsibilities:

• Analyzed samples for metals GFAA
• Analyzed for various gases by GC/MS
• Maintained equipment, make - up working standards for metals analysis, calibrated laboratory equipment as required
• Draw samples of products and conduct quality control tests to monitor processing and to ensure that standards are met, reported results to Control room for adjustments in the plant
• Perform laboratory validations for all instruments utilized in the analytical lab for lab certification as well as accuracy and precision for qualitative and quantitative reportability
• Maintain documentation of validation parameters for qualitative and quantitative reporting
• Adhere to SOPs and LOPs established methods

Confidential, OKC, OK

Sr. Chemist/Inorganic Lab Supervisor

Responsibilities:

• Trained wet chemistry lab technicians and performed annual reviews
• Wrote and Implemented SOP s and LOP s for Inorganic laboratory
• Performed instrument and method validation for laboratory certification and the establishment of working SOP s and LOP s for both accuracy and precision of qualitative and quantitative results
• Record test data and prepare reports, summaries, or charts that interpret test results
• Maintained laboratory certification with performance testing for EPA WP, NIOSH, AOAC, NIOSH/ELPAT
• Maintained all calibration and working standards for inorganic laboratory
• Maintained inorganic and wet chemistry laboratory equipment and calibrated equipment when necessary
• Ordered chemicals, equipment, and supplies for wet chemistry laboratory and Inorganic laboratory
• Performed various extractions for various companies including liquid and solid phase as well as experienced in leachable extractions.
• Trained employees on various analytical methods including density, TDS, TSS, rheology, HPLC,UV - VIS spectrometry
• Implemented LIMS system for EPA regulated Analytical Laboratory
• Compliance with all regulatory, quality, and safety requirements