Cherie Parker

*** ****** ***** ***** ( Smyrna, Tennessee 37167

Home: 615-***-**** ( Cell: 615-***-**** ( abhkgd@r.postjobfree.com

MANAGEMENT: Regulatory Affairs & Quality Assurance

Quality control and regulatory professional with over 10 years of

professional experience in pharmaceutical, biotechnology, medical device,

food and clinical trials auditing. Proven ability to analyze, troubleshoot,

and improve manufacturing processes and products. Expertise in quality

system management and manuals. Demonstrated skill managing programs and

projects to meet requirements for budget, schedule, and accuracy. Versed in

training and supporting technical employee teams.

Core Competencies

Regulatory Compliance ( Laboratory Management ( Current Good Manufacturing

Practice (cGMP)

Quality Assurance & Control (QA & QC) ( Food Safety & Security ( FDA Rules

& Regulations

Clinical Trial Studies ( Process Validation ( Standard Operating Procedures

(SOPs) ( ISO

Internal & External Audits ( Clean Room Environments ( Cost Controls &

Reduction ( Sterilization

PROFESSIONAL EXPERIENCE

Amsino Medical USA, Nashville, Tennessee ( 2009 to Present

Class II medical device manufacturing company with over 130 employees and

class 100 clean room.

Regulatory Affairs Auditor

Monitor and analyze clean room environment and controls, identify

noncompliant processes, and initiate cleaning and corrective action to

ensure safety and avoid legal exposure and manufacturing down time. Write

protocols and coordinate studies to validate manufacturing processes.

Develop procedures and audit manufacturing, quality, sterilization,

stability studies, distribution, purchasing, and supply chain for cGMP,

ISO, and FDA compliance. Recommend new equipment purchases.

. Reengineered QA group, streamlining quality technician forms/SOPs and

retraining technicians. Reduced out-of-limit samples by 25% and

microorganism costs by 25%.

. Started quarterly dose auditing program by contract sterilizer for

terminally sterile product.

. Launched supplier/services audit program, devised and deployed risk-based

supplier monitoring and audit system, and audited Chinese supplier.

. Processed sterile instruments used to manufacture medical devices.

. Validate hydrogen plasma sterilizer used to decontaminate cleanrooms.

. Electronically filed drug registration and listing on FDA's website.

. Authored 510(k) submission for medical devices.

Advanced Breath Diagnostics ( 2008

Quality Assurance Manager

PMA was not approved by FDA, so position was canceled.

Audited lab technicians ensuring compliance with GMP procedures. Conducted

gap analysis on the quality management system eliminating noncompliance

issues found in drug and medical device products. Wrote procedures.

Responsible for control of quality systems documentation. Assisted with

maintenance of cell banks and harvesting of algal material used for product

manufacturing. Maintained clinical trial documents.

Food & Drug Administration, Nashville, Tennessee ( 1998 to 2008

US government food, pharmaceutical, and medical regulatory agency with over

11,000 personnel.

Consumer Safety Officer

Investigated and inspected a wide array of clinical trial studies, and

food, pharmaceutical, medical device manufacturing facilities, and

products. Identified violations, and recommended corrective action to

corporate and government personnel. Planned regulatory programs, developed

inspection methods, and maintained inspection schedule. Analyzed quality

management systems, processes, and equipment for regulatory compliance, and

documented/reported results. Coordinated food safety incentives and food

security/defense with Tennessee Department of Agriculture. Trained and

mentored new investigators.

. Saved over $20,000 through consolidation of time and travel efforts on

inspections.

. Audited more than 40 medical devices, initiated 6 regulatory actions and

received multiple merit awards for task force service.

. Earned service awards for performance during Hurricanes Katrina and

George, and after tornadoes in West Tennessee.

Country Delite Farms, (a Dean Foods Company) Nashville, Tennessee ( 1996 to

1998

Private dairy product manufacturer with over 100 employees, a subsidiary of

Dean Foods.

Food Technologist / Quality Control Specialist

Tested and evaluated raw milk and a wide array of finished products,

informing management and government agencies of issues. Inspected plant for

microbiological contamination and drove cleaning/resolution to improve

public safety and company image. Streamlined processes and documents to

boost technician efficiency and accuracy. Ensured timely test result

delivery to production supervisors, avoiding shutdown of lines.

. Saved $180,000 by identifying antibiotic in raw milk, preventing

contamination of 60,000 gallons.

. Designed rotating holiday/weekend schedule to enhance employee morale.

. Certified by FDA and state of Tennessee to test milk.

Perriago, Smyrna, Tennessee ( 1989 to 1996

Health and beauty manufacturing company with more than 1,200 staff.

Lead Microbiologist

Analyzed raw materials and finished products, validated sterilization

equipment and systems, and reported results for corrective action. Achieved

optimum release of final products.

. Validated autoclaves and sterilized media and instruments used in

microbiology lab.

. Reduced costs and contamination through troubleshooting of de-ionized

water treatment system.

. Chosen for team improving QC and material handling. Earned Team Materials

Gold Award.

Early Career (details on request):

. Food Technologist, Mrs. Kinser's Salads

. Quality Control Manager, Kentucky Sausage Company

FORMAL EDUCATION

Master of Science, Food Technology & Science

Bachelor of Arts, Microbiology (Minor in Chemistry)

University of Tennessee - Knoxville, Tennessee

CERTIFICATION & TRAINING

. FDA Certification and training: Quality System Regulation (Medical

Devices), Quality System Inspection Techniques, Hazard Analysis &

Critical Control Points (HACCP) Food Safety, Food Security & Defense,

Good Manufacturing Practices for Foods, Pharmaceuticals, & Medical

Devices

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