- MS Office Suite (Word
- Project Management
- Advanced Excel (V - Lookup
- Pivot Tables
- QMS (Quality Management Software)
- Electronic Batch Record Management (EBR)
- Compliance Wire
Confidential - Johns Creek, GA
R&D Quality Engineer (Contractor)
- Performed Document Creation (SOP’s, Guidance, Training), review and/or approval of records for Atlanta R&D division including laboratory notebooks, equipment logbooks, batch records, protocols and reports among others.
- Provided hands on support for quality management training systems such as cGDP (Good Documentation Practices), document control, training records, training materials, delivering quality training throughout R&D facility.
- Support and perform internal, corporate and external audits of Atlanta R&D and Manufacturing facilities.
- Supported management teams by generating maintenance documentation for approval of suppliers for R&D facility.
- Ensured proper Quality Systems, Procedures and Protocols were maintained and in compliance via R&D Facility audits to ensure the facility was 21CFR compliant, as well as in compliance wif various international regulatory agencies.
- Support local Quality and Design Control related projects as needed for Atlanta R&D facility.
- Provided routing reporting requirements for the various compliance forums including Quality Council, Management Review, Quality Plan Performance Meetings, routing QMS software (TrackWise, Windchill, LIMSetc.) dashboard reporting for Novartis and Alcon, and all other reporting as needed in order to maintain compliance.
- Actively participated in Production Triage Team as Lead Quality Engineer member by providing direction and support on non-conformance process, product impact assessment, root cause analysis and product quarantine as non-conformances arose at facility.
- Ensured non-conformance reports were initiated as per Federal Guidelines and applicable activities were identified and corrective actions implemented in order to mitigate adverse issues and events.
- Performed Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing/disposition non-conformance records for quarantine release and removal of product from quarantine area.
- Interacted wif diversified, multifunctional, and cross-functional teams such as Manufacturing, Operations, Quality Engineering, Compliance, Regulatory and Engineering to improve processes and increase product quality.
- Audit and review R&D research laboratory manuals, instrument log books, batch records and various other documentation to prepare and support Regulatory Department for new medical device product design and development as well as pre-clinical, and clinical trials in preparation for submittal of 510(K) application for new medical device.
Confidential - Covington, GA
Quality Assurance Supervisor
- Accountable for the development and retention of qualified temporary and permanent staff to handle a large volume of complaints and adverse event reporting
- Compiled complaint data and electronically filed Medical Device Reports (eMDRs) to FDA via eMDRs and Alternative Summary Reports (ASR) wifin the required time frames
- Developed reports via QMS Software (TrackWise, LIMS, etc.) and extrapolated data into Excel to identify and correct issues wif the complaint workflow in order to meet or exceed departmental goals and objectives
- Revised new employee on-boarding policies, training practices, team building orientation and talent development processes
- Participated in the development of Kaizen’s, Value Stream Map (VSM) and implementation of Future State Map (FSM) goals wifin department to streamline and improve complaint entry processes
- Interacted wif medical device manufactures ensuring complaint, AE, and distributor reporting responsibilities were met
- Monitored daily workflow of Legal FA team members by accessing data from TrackWise and compiling reports into Excel spreadsheets in order to quantify departmental throughput
- Collaborated wif upper management to complete and investigate Corrective Action Preventative Action (CAPAs) plans as well as implementation of corrective actions wifin QA department (Utilized 5-Why’s, Fishbone, Rootcause etc.)
- Performed QA approvals as well as approved Decision Reference Forms (DRFs) and reviewed DFMEA’s, DHR’s on completed complaint investigations
- Maintain required records in accordance wif GDP and FDA guidelines
- Work in BSL2 CleanRoom, receive blood borne pathogens, and various other bio-Burdon materials according to GLP
- Review Standard Operating Procedures (SOPs) for accuracy, write new SOPs, redline SOPs and submit change requests in accordance wif regulatory and corporate guidelines
- Participate in and provided support in Corporate and FDA audits of departmental policies, procedures, protocols and complaint reporting documentation, SOP’s and various other pertinent Quality issues.
- Audited, revised and submitted departmental annual budget to upper management for approval.
- Consistently met wif executive management to determine throughput, headcount as well as all other issues that were pertinent to departmental metrics
- Attended and presented in meetings wif VP of Quality Assurance as well as Company Controller to determine annual growth, headcount, and resources needed to continue special projects and remain compliant wif company’s obligations and accountability wif FDA, as well as all other Federal Guidelines and regulations.
- Conducted meetings (and remained point of contact) wif FDA in relation to MAUDE Reporting, Alternative Summary Reporting (ASR), Medical Device Reporting (MDR), Adverse Event and Catastrophic Event Reporting as well as all other issues in relation to complaint handling and reporting wif the FDA as well as Third Party Device Reporting agreements and obligations.
- Project management, managed interdepartmental teams (Initiation, Investigation, Medical Records Review and Reporting), in terms of Adverse Event Reporting and throughput in order to meet monthly metrics, throughput and remain complaints wif FDA 21CFR reporting guidelines.
- Received and entered product complaints into Quality Management System (QMS, TrackWise, LIMS, etc.) in accordance wif FDA and Regulatory guidelines, submitted eMDR’s in accordance wif regulatory guidelines, GDP and 21CFR803 and 21CFR820.
- Review and approve adverse events decision trees in Trackwise (Domestic and International).
- Analyze complaints and adverse events and communicate issues and resolutions to management. Generate monthly Adverse Events and Complaint Trending Reports.
- Performed product investigations, DHR investigations, DFMEA investigations and coordinated various issues wif Initiation, Medical Records Teams as well as management.
- Designed, developed and ran custom reports in TrackWise (QMS Software), as well as extrapolated data into custom Excel files and submitted to management for monitoring throughput in order to meet team goals.
Confidential - Lawrenceville, GA
- Supervised 10 employees in the facilitation of daily functions throughout facility, such as daily QA/QC checks/audits, Batch Record Compliance/Protocol, Upstream/Downstream Processing, CIP, SIP, BIP in accordance wif ISO 14001, ISO 9001 and various other EPA guidelines
- Prioritized microbiology and fermentation timelines to ensure regulatory and EPA guidelines were met
- Designed individual team performance methods and metrics to prioritize and develop goals for fermentation runs and microbiology laboratory QA/QC checks for executive management
- Manage microbiology laboratory technicians in performing quality control testing on fermentation and production runs throughout various stages of manufacturing process (Upstream and Downstream processing)
- Directly supervised individuals including talent identification, mentoring, performance improvement/management, staffing decisions (hiring, interviewing), prioritizing of resources, etc.
- Train Inside/Outside Sales Reps on products, compatibility, EPA/EPD/USDA guidelines and compliance
- Develop SOP’s for microbiology laboratory and fermentation departments, issue CAPA reports and investigations
- Perform one-on-one mentoring wif technicians, quarterly/annual performance evaluations and reviews
- Recommended yearly budgets and implemented prioritization of disbursement in accordance wif departmental labor, materials, R&D and equipment needs
- Train microbiology and fermentation technicians on GDP/GLP/GMP processes and procedures, work in BSL 2 CR
- Designed, developed and implemented LEAN-manufacturing principals to streamline fermentation and QA/QC processes throughout facility using QMS Software (LIMS, Formulator, Excel, V-Lookups, Pivot Tables, etc.)
- Designed and developed custom Excel programs in order to track usage and re-supply of working seed inventory
- Performed Root Cause analysis of various microbiology, fermentation and production processes to identify and eliminate major contamination issues
- Generated Batch Records and reviewed them for accuracy throughout production process and batch runs
- Experience working wif customers on an individual level
- Long term back-ground in working in a fast-paced environment between many cross-functional teams and departments
- Experience wif cGDP/cGLP/cGMP, Lean Manufacturing, Clean Room, BSL Level 1, BSL Level 2, Gown up procedures, EPA, FDA, ISO (1300, 1400, 9000), 510K, 21CFR 803 and 21CFR820, 21CFR210/211
- Developing teams
- Strong interpersonal skills (verbal and written communications, customer focus, telephone manner, professionalism, coaching, influencing and team building)
- Strong analytical and problem solving skills
- Highly motivated, detail oriented, efficient
- Strong listening and assessment skills
- Biotechnology, Fermentation (upstream and downstream), Microbiology (aseptic technique, streak plate, BSL 1&2)