Quality Medical Device

Grace C. Briggs

Contact: 919-***-****

*************@***.***

SUMMARY:

Over 18 years of cGMP/cGLP and cGCP leadership in biological aseptic and compliance of pharmaceutical/medical device (combination) QA/QC regulatory environments.

Managed/operated with adhering to 21CFR part 210/211/803/820/58 and ICH guidance Q7 in ISO 9000/ 13485/14971 environments along with cultivating quality teams to commit to integrity and ownership.

Directed/conducted audits and investigations, risk assessments for medical device and pharmaceutical regulatory environments, remediation/design of biology labs, supplier audits, provided GMP and/or GCP compliance consulting services, conducted training, and managed, compliance related QMS projects (deviation identification and initiation of containments/ investigation/method review/mapping process/gap analysis/root cause analysis/and risk assessment-FMEA) for clients and stakeholders world wide along with building/integrating cultivated quality teams.

Security knowledge and training in SOX/DEA/TSA and 21 CFR part 11.

Reported/Directed management on factual findings, interprets facts and provides compliance opinions, and makes recommendations for steps to take to address reported findings/deviations. Directed and performed investigation, defining root cause analysis for deviations. Provided visual aids of Method One tools and Mapping processes.

Involved in leading self driven projects and projects collaborating with quality circle teams to gain diverse information that supports process improvement for remediation efforts (may work alone or as part of a team).

Strong knowledge in QMS principles in related to assignments that often involve technical and regulatory considerations where precedent is not clear, and therefore my professional expert technical and regulatory knowledge and good judgment are needed to guide client decisions and considerations in remediation efforts in FDA observations/483 environments.

Gowning Certified in multiple Sterile Aseptic (5A-9D classification areas)/ and Non Sterile Environments.

Implemented validation improvement on CIP/equipment calibration/PM/QSR in cleanroom environment with FMEA.

Directed and performed GDP/change control /record retention

Strong at auditing, investigating, quality managements systems, leading change control, document review, risk assessments and making decision based on CFR guidelines/laws (Medical Device/Biotech).

Quality skills proven to eliminate audit concerns and specialize in helping put solid effective control for CAPA’s to resolve complex issue and maintain audit ready environment in cGMP to eliminate potential FDA 483 and consent decree by outlining/implementing plans that adhere to quality ISO guidelines to maintain cGMP/cGLP audit ready environments.

Change Control documents and Technical Writing (SOP’s review/revision/and work instructions)

Established knowledge/expertise in CIP and starting up clean room environments for liquid /medical device kits/ and semi-solid dose. Monitored/Reviewed process of operation for Bulk tank sampling in solutions.

Revised / edited batch records to reduce production errors and potential eliminate audit concerns.

Reviewed production batch record/laboratory batch records/ work instructions, stability testing, MDR, MDHR and APR

Performs vendor/supplier audits, internal/external audits, reviewed the quality management system for the authorized supplier, wrote audit reports, documented closeouts, monitored the supplier audit schedule for accuracy, communicated with stakeholders to manage the quality of pharmaceutical liquid /semi solid dose/medical device vendors, supported audits of regulatory agency inspections, and provided support/knowledge of guidelines for new product initiatives.

Proven quality skills that drive conformity in leading pharmaceutical companies that were facing non-conformity with audits/CRO/CMO/EMQO.

Procurement. (Knowledge of supply contracts, value analysis, removal or disposal, inventor control, master vendor list research selections, authorized suppliers, and performance of quality audits.

Team focused quality skills that led to eliminating or minimizing non conformity by supporting effective validation engineering process (FMEA)/QSE and implemented actions plans (CAPA) that lead to solid controls for major medical devices and pharmaceutical companies.

Proficient with maintaining validation and developing quality manual /systems (audits)

Experienced/knowledgeable in leading biological testing/ Blood Reagents/ and Cell Culturing.

Knowledgeable in cGLP/cGMP/ISO 9000/13485 and Editing SOP’s (technical writing skills).

Internal/External GMP audits and knowledge in CRO/CMO with internal and external auditing.

Reviewed plant wide batch records/COA’s for adherence to daily operating practices and procedures.

Quality audits of suppliers, filling, packaging and finishing lines with operating in regulatory environment

Led Monthly cGMP Quality staff meeting/project management (CAPA)

Investigate and follow up with upper management on open items that could be a possible FDA audit concerns

Organized cGMP/Safety training for manufacturing, contractors and third party evaluations with SOP’s and audit guidelines.

Drug Safety-DEA, API’s, DS, and DP, raw drugs, in process drugs, finish product, and packaging experience.

Micro biologist/Bioburden/Clinical trial/laboratory experience (medical device, pharmaceutical – liquid, powder, and solid dose/ biotechnology).

Certified with Aseptic, Isolators, Freeze Dryer, and TS processing (LVS, VisIV, Partfill, and Flex).

Porex Filtration Group Global Life Sciences May 2016 -- Current

Designated Quality Assurance Engineer 5/ SME cGMP Facilitator

Fairburn, GA

Primary Responsibilities:

Create and review regulated documents associated with the design and manufacture of products

SOPs, specifications, testing protocols and reports, quality control and reliability plans etc.

Provide guidance, review and support on improvements to production and process controls, including

handling of nonconformities

Audit suppliers for compliance with quality requirements, regulations and international standards, observe

processes and identify opportunities for improvement.

Review in-process and final product specifications to evaluate and set quality requirements

Participate in devising and implementing methods and procedures for inspecting, testing and evaluating raw

materials, components and finished products

Provide advanced techniques to ensure that quality is designed into products and processes, including

Design/Process FMEA/HA, DOE, statistical process control, Six Sigma, etc.

Perform analysis of production and process data to identify trends and recommend improvements to

processes and procedures to reduce and control manufacturing process defects

Provide guidance on the development of verification and validation plans, test and sampling methods, sample

size determination and acceptance criteria

Provide quality perspective in support of design control and change control activities

Leads or participates in cross-functional teams to support new product development, quality improvement,

and cost savings projects

Provide support on the assessment and disposition of nonconforming material

Provide support on CAPA investigations and effectiveness assessments

Regularly interacts with other departments and suppliers regarding quality matters (Aseptic/TS)

Risk Assessments/Gap Analysis/Deviation Investigations/Root Cause Analysis

Provide staff training on regulatory requirements, specializing in GMP/QSR

Perform other related duties as required Regulation environments OSHA/EPA/EU/FDA 21CFR820/210/211/part 11.

Operational Quality Systems Improve Experts (OQSIE) August 2015 – May 2016

ST. Louis, MO

SME consultant on site at Meridian-Pfizer, and Xellia

Endeavor/ Belcan Engineering/NNE/SME QA Consulting

J&J/DSM/Patheon/ and Virbac Company(CMO) May 2014 – August 2015

Greenville, NC/ Shepherdsville, KY/ST. Louis, MO

SME consultant/Leading global/domestic quality meeting and performed quality audits/investigations (CAPA) to eliminate audits concerns in preparation of regulatory audits for batch review, risk assessments, Inprocess, Finishing and Packaging processes. QA oversight for validation and combination medical devices and aseptic filling process, gap assessment for routine cleaning and clean room techniques, CIP, stability testing, error proofing quality system to support current operating procedures.

Quality skills proven to eliminate audit concerns and specialize in helping put solid effective control for CAPA’s to resolve complex issue (investigations/root cause analysis/risk assessments) and maintain audit ready environment in cGMP to eliminate potential FDA 483 and consent decree by outlining/implementing plans that adhere to quality ISO guidelines to maintain cGMP/cGLP (Micro Biologist Analyst) audit ready environments.

Analyzed corporate policy with gap analysis/ quality shadowing/and risk assessments. Supported training with quality teams/instructed on current practices and potential noncompliance issues (deviations). Implemented corrective action plans and documentation to support effective controls to regulatory government bodies.

Red lined master files against supported documents to capture gaps in aseptic technique / sterility cleaning.

Change Control documents and Technical Writing (SOP’s review/revision/and work instructions) to support current practices in sterile environments for operation/validation (IQ/PQ). Reviewing/Monitoring QA oversight for bulk process in solution.

Established knowledge/expertise in biological cGMP/ CGLP/cGCP to progress in the company’s QA/QC quality systems for liquid /medical device kits/ and semi-solid dose in aseptic and non-aseptic environment.

Revised / edited batch records to reduce production errors, reviewed/supported cleaning validation protocols, outlined errors in stability documents against SOP’s and potentially eliminated audit concerns.

Reviewed production batch record/laboratory batch records/ work instructions, stability testing, MDR, MDHR and APR

Performs vendor/supplier audits (components), internal/external audits, reviewed the quality management system for the authorized supplier, wrote audit reports, documented closeouts, monitored the supplier audit schedule for accuracy, communicated with stakeholders to manage the quality of pharmaceutical liquid /semi solid dose/medical device vendors, supported audits of regulatory agency inspections, and provided support/knowledge of guidelines for new product initiatives.

Proven quality skills that drive conformity in leading pharmaceutical companies that were facing non-conformity with audits/CRO/CMO/EMQO.

Procurement. (Knowledge of supply contracts, value analysis, risk assessments, equipment validation/calibration PM, removal or disposal, inventor control, master vendor list research selections, authorized suppliers, and performance of quality audits to support cGMP.

Confidential Biotech Company (CMO) September 2013 – October 2013

Bridgewater, NJ

SME consultant/Led quality meeting to eliminate audits concerns in preparation of GMED audit.

Quality skills proven to eliminate audit concerns and specialize in helping put solid effective control for CAPA’s to resolve complex issue (investigations/root cause analysis/risk assessments) and maintain audit ready environment in cGMP to eliminate potential FDA 483 and consent decree by outlining/implementing plans that adhere to quality ISO guidelines to maintain cGMP/cGLP audit ready environments.

Change Control documents and Technical Writing (SOP’s review/revision/and work instructions)

Established knowledge/expertise in biological cGMP/ CGLP (Analyst Micro Biologist)/cGCP to progress in the company’s QA/QC quality systems for liquid /medical device kits/ and semi-solid dose in aseptic and non-aseptic environment.

Revised / edited batch records to reduce production errors, reviewed/ outlined errors in stability, gap assessment of cleaning validation documents against current practices/ SOP’s and potentially eliminated audit concerns.

Reviewed production batch record/laboratory batch records/ work instructions, stability testing, MDR, MDHR and APR

Performs vendor/supplier audits, internal/external audits, reviewed the quality management system for the authorized supplier, wrote audit reports, documented closeouts, monitored the supplier audit schedule for accuracy, communicated with stakeholders to manage the quality of pharmaceutical liquid /semi solid dose/medical device vendors, supported audits of regulatory agency inspections, and provided support/knowledge of guidelines for new product initiatives.

Proven quality skills that drive conformity in leading pharmaceutical companies that were facing non-conformity with audits/CRO/CMO/EMQO.

Procurement. (Knowledge of supply contracts, value analysis, removal or disposal, inventor control, master vendor list research selections, authorized suppliers, and performance of quality audits.

Immucor, Inc. (Leading in Blood Transfusion) April 2013-July 13

Norcross, GA

Primary responsibilities were providing cGMP/cGLP SME to the process areas of the company that were in non compliance with adhering to ICH Q7A guidelines and 21 CFR 210/ 211/ 820/ part 11 CFR laws. In less than two months reviewed several SOP’s and shadowed the Red Blood Cell process to capture non conformities. Lead non conformity projects/FDA observations/and quality audits.

Directed team meetings on projects for CAPA (investigations/root cause analysis/risk assessments) / potential compliance issues with consultant teams to set up solid control to produce safe quality products. Reviewed completed batch records and authorized final signature on final batch records.

Conducted remote QA/QC activities between multiple facilities of Red Blood Cell processes to implement action plans that adhere to Lean and Six Sigma. Monitored and investigated several labs testing techniques for integrity/accuracy. Immediately found bottle necks in process and revised SOP’s to support current operating procedure in lab environment.

Performed Audits, Validation Protocols, FMEA-Root Cause, Document Change Control and GAP analysis in aseptic environments.

Revised / Edited Batch Records to reduce production errors

Reviewed Production Batch Records/Laboratory Batch Records/ APR/and DHR

Performed technical writing and gave presentations to senior management

Investigated customer complaints (VOC)/Aseptic techniques were monitored

DMR/DHR for annual review/ traceability of accuracy.

Edit SOP’s/Control Documents/Change Control

Processing quality output and control for suppliers, COA. ASL/Procurement

Review Quality Systems/files Medical Device 13485 (Sterile and Non Sterile) Audits

Validation process/Biological equipment knowledge/Micro Biologist analyst GLP

ISO environment 9000/13485 (performed gap assessment to capture non conformities in daily manufacturing operations).

Consultant/BD Women Health and Cancer- medical device- (Diagnostics) May 12-December 12

Burlington, NC

QA cGMP/cGLP CAPA Project Compliance Specialist/SME cGMP Compliance Project Team Lead

Primary responsibilities specialize in helping companies that are at risk of potential audit finding by external auditors (FDA) in aseptic environments with documenting using QMS. Coached and supervised teams with directions (investigations/root cause analysis/risk assessments) of proven quality skills that led to implementing actions plans and putting solid controls in order to eliminate any non conformity. Review validation, manufacturing, laboratory practices, batch records and annual quality review to make sure they adhered to cGMP/cGLP/CFR 21 Part 211 and reviewed/revised SOP’s.

Managed and completed document change control risk assessments, CAPA’s in ISO 9000 and 13485 environments that had trends and history of inadequate action plans and failed controls by resolving the issues with reviewing current practices and updated SOP’s to support operational practices, performed FMEA to analyze priority of risk and conducted effectiveness check to make sure accurate and efficient controls were put into place in cGMP/cGLP (Micro Biology environments). The managing and implementing of the solid controls was a great success in a short time frame, because the CAPA’s had been previously open for a period of three years. The CAPA’s were closed in a timely manner under my leadership with supported team effort with true effective controls in place before the next scheduled external ISO audit.

The teams that were managed under my guidance have gained knowledge and training to maintain a safe, quality environment driven to eliminate any potential FDA audit concerns.

Monitored and established a solid supplier global program to include in compliance AQL and supported external audits.

Abbott Laboratory/Hospira Rocky May 03-May 11

Mount, NC

Environmental Facility Monitoring /cGMP Compliance Supervisor Engineering Dept.

Primary responsibilities are to supervise the department cGMP quality audits in primary aseptic environments, initiated deviation reports, addressed potential product impact (risk assessments), quality gap assessments, supported/ outlined remediation plans and solid effective controls. Trained employees on technical equipment and operations, QA oversight of cGMP clerks, PM program, engineering maintenance dispatchers, cGMP compliance specialists, inspect and lead/schedule audits in a facility that is over a million square feet, inspecting several EMQO/CMO in a cGMP aseptic environments, reviewing batch records, monitoring MP2/Weblink system with limited headcount. Help implement and update the RM Checklist Program by monitoring, generating and approving maintenance and manufacturing work orders daily. Support manufacturing operations with cGMP compliance items. Direct meeting to assist in closure on high priority work orders. Also implemented corrective actions and error proof inspections for all work orders that are completed to ensure accuracy and conformity to standard documentation practices adhering to cGMP and CFR 21 Part 211.

Involved in several special cGMP/cGLP quality manual and system projects including auditing, IQ, PQ, developing training quality modules/ISO train for FMM supervisors, supporting the electronic work order system, developed and maintained the compactor SOP B8000_0008 to contain equipment procedures, outlining a pandemic plan for facility, completed a lean project by eliminating wasted space and organized the area, merged the SVP dispatch with supporting FCF Safety and Facility maintenance issues, and reviewed /edited PM & SOP to support current practices. Engaged with internal PM audits, eliminate potential audit concern for PMs and support the handling of the control documents. Also efficient with company systems such as AS400/MP2 and Weblink (CMMS) and continued to promote process improvement with Lean and Six Sigma knowledge.

Investigated, inspected and provided help to put in place a cGMP matrix program for classification of manufacturing designated areas for quality internal audits, cGLP training in Micro Biology Labs, CMO, and EMQO. Introduced the matrix to Facility Monitoring Manager 10/06. Estimated over 105 priority 1 work order reflected the new matrix standards in months of November and December (history reflects only 3 priority 1 were recorded in 2006, before the matrix standards were put in place) using a quality system similar to SAP

Worked independently, efficiently, and accurately with limited support of a full functioning department for a total of five months before Kelly Services found qualified candidates. Independently approved and tracked 754 work requests from 11/18/05 through 06/30/06. Also, played a major role in performing approximately 319 cGMP internal audits from 01/01/06 through 8/17/06 that help eliminate/minimize potential audit concerns. In addition, made several revisions to the Room Checklists SOP that reduced the checklist errors and increased the effectiveness of room inspections from 2003 to 2011. Implemented and trained direct employee on cGMP and classified/controlled environments. Improved controlled document errors by implementing error proofing.

Helped implement a scrap metal recycle program with a vendor. Also, helped implement the paint color scheme/volume of paint supplies for the facility with a vendor. Applied a 5s lean project in compactor room. Created procedure on how to operate compactor room equipment. Supported employee labor cost reduction by involuntarily supporting cost reduction for employee labor in Housekeeping Department by being subjected to high employee turnover. Intermediately coached the facility paint/floor crews.

Conducted routine staff meeting with upper management on potential FDA concerns. Initiated follow cGMP training with department managers to support CAPA. Assumed additional supervisory responsibilities that included cGMP clerk, cGMP compliance specialists, PM clerks and seven central maintenance dispatchers (supervisory roles expanded to 32 employees direct reports). Audit one of the largest manufacturing facilities in North Carolina that is over a million square feet that included an Isolator fill lines, review final validation protocols, IQ. PQ of new equipment and temperature mapping of storage areas. Help implement an air flow chart to the SOP B8000_0001 to eliminate possible audit concern. By 2011, I directed over 4,000 internal audits and trained over 2,000 employees on cGMP program/Quality systems.

Bayer Biological Pharmaceutical June 99-March 02

Clayton, NC

BQA Environmental Monitoring Technician/Micro Biologist Lab Technician (Blood Pathogens)

Supported the auditing program, validation of the new sterile filling Facility, supervised the media runs, reviewed production batch records, laboratory batch records, document change control, validated IQ,PQ for solutions tanks, mapped temperature in warehouse areas, monitored the validation tests for the CA/water ports, built strong effective relationship with quality team members, edited SOP’s to current practices to eliminate potential FDA concerns, and initiated follow cGMP training with several department managers to support CAPA (investigations/root cause analysis/risk assessments). Also assumed additional responsibilities for reviewing process improvement in manufacturing/labs, outlining aseptic training matrix new hire for managers, operators, and contractors on cGMP/cGLP in aseptic environment.

Primary routine responsibilities reviewed the monitoring of Class: A sites in critical control areas that immediately surrounds exposed product.

Monitored Class: B environments that are critical areas surrounding Class: A sites

Monitored each aseptic fill line daily when in use and portable laminar air flow with viable air using TSA plates(Andersen Housing), non-viable air using particulate counter and rodac contact plates

Monitored using settling plates at set up areas for liquid and semi solid dose.

Monitored sterility environment/Media Runs

Combination products (aseptic prefilled syringes)

Trained employees on technical equipment and operations.

Issued Aseptic Training/Inspected operators’ techniques.

Stability

CGMP & CGLP

Tested Plasma/Bioburden tests/Mold testing/and water purification testing.

Monitored R&D Labs

Supervised OAL Meeting

WFI/HWFI/ LAL/Equipment Sampling/Validation

Microbiologist Lab Technician testing (sampling/raw/in process/finished)

Sherwin Williams Company Sept 98 - June 99

Chapel Hill, NC

Assistant Manager

Determined and resolved problems related to management reports

Managed Budget (first six months reached goal for million dollars’ sale)

Managed operator technicians and coached process improvement.

Monitored and assisted in physical inventory in a timely and accurate manner

Managed/supported the master vendor list for authorized vendors

Trained employees on technical equipment and operations

Ensured safety (OSHA/EPA), loss prevention, and security guidelines were complied

SPECIAL PROJECTS:

Florida Keys Field Study: Scoped environmental problems, surveyed nature and translated lab studies to onsite identification of species in the wetlands.

Senior Project NTSC: Examined the principles and applied techniques to a biological field investigation of algae, soil, and water testing that culminated into a senior research paper under instructor supervision.

Green Belt Project (Under Utilized Fork Trucks/Eliminated Truck Rental): Received certifications in Six Sigma Greenbelt 8/08. Participated on team that supported a cost improvement project that generated saving of $70,000 in 2008 cash f low.

Lean Project: Received certifications in Lean Manufacturing 9/07

Developed templates to uniform or integrating templates for performing investigations/root cause analysis/and risk assessments to provide solid quality controls.

Minimized the release time on commodities and eliminated/organized the space in the compactor room.

CGMP Projects: Developed the cGMP audit program, checklist, training modules/ISO train and risk assessments for FMM supervisors, supervised change control, revised the Compactor SOP B8000_0008 to contain equipment procedures, implemented the Facilities Emergency Evacuation Control Plan (SOP ENGFACEVAC), and edited the PM SOP B7100_0255 to support the current practices of the daily operation in production/facility by unifying maintenance PM/GMP forms throughout the entire plant. In 2011, edited cGMP SOPB8000_0001 to improve process and eliminate potential audit concerns and performed critical investigations. Proceeding in 2012 to managed and led teams in ISO 9000/13485 environment to resolve complex issue with trends and backlogs of CAPA’s to a success of implementing action plans that trigger solid effective controls. Reviewed work order, change control system, batch record, APR, MDR, and MDHR for accuracy and completeness in cGMP environment. Performed critical cGMP internal/external audits.

The closing of the CAPA’s transitioned to an external auditing being satisfactory (awarded ISO recertification) without any documented non conformities. In 2013, SME cGMP Consultant for Red Blood Cell company that was leading in blood transfusion medical device -distributed proven knowledge of cGMP The teams that were managed under my guidance gained knowledge for continues process improvement and training to maintain a safe, quality environment driven to eliminate any potential FDA audit concerns.

Project management of suppliers (ASL) and supplier external audits

CERTIFICATIONS/PROFESSIONALTRAINING:

Proficient with cGMP/cGLP 21 CFR 210/211/58/820/part 11 and ISO 9000/13485/14971

Aseptic Certified

Micro Biology Testing/cGLP

Batch record review, work instructions, APR, MDR, and MDHR for accuracy and completeness.

Highly knowledgeable in cGMP/cGLP internal and external audits

CAPA 21 CFR 820.100/Technical writing SOP’s/ and document change control (editing, authority, security, archiving and part 11).

Outlining strategies to eliminate internal and external audit concerns

CAPA/Technical writing SOP’s (review/revision/ document change control and remediation)

Medical Device/Pharmaceutical (combination devices, semi solid dose, & liquid dose)/Biotech (blood pathogen)

EMQO/CRO/and CMO

Edit/review control document support 21 CFR 820.40 (Change control process knowledge)

Procurement/Authorized Suppliers

Quality systems/ risk assessments/method review (scope)/processing mapping/validation process and FMEA

Conducting quality staff meeting

Internal/external cGMP audits

cGMP compliance supervisor engineering dept.

Combination medical devices/Aseptic filling and packaging

ASQ Member

Micro and LAL sampling/ biological processes

Certificate in Lean Training-Hospira

Certificate in Six Sigma Green Belt Training-Hospira

Certificate in Management Training Program-Assistant Manager (Sherwin Williams)

Directed internal and external audit in Aseptic/Isolators/TS/Freeze Dryer/FCF/SVP/Part-Fill with ISO guidelines.

Excellent written and oral communication skills

Strong influencing and negotiating skill without direct line authority

Proven record of leading teams in delivery of solid results.

Ability to manage change effectively and deliver timely decisions with minimal information

Process orientation and ability to evaluate issues from a work flow perspective

Experience in a medical device or pharmaceutical regulated environment.

EDUCATION:

Bachelors of Science December 1997

ShawneeStateUniversity, Portsmouth, OH

Major: Natural Science with concentrations toward Biology, Math, and Chemistry

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