Quality Assurance/Regulatory

Melissa Basnight

***** ******* ****

Santee, CA *2071

Cell: 619-***-****

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

Summary of Qualifications

A highly motivated professional with 20 years of experience within the pharmaceutical, diagnostics and medical device industry in regulatory and quality management positions. Strengths include:

• Regulatory/quality knowledge of OIG, PhRMA code, GLP, cGMP, 21CFR58, 21CFR 820, 21CFR 210 and 211, 21CFR Part 11, QSR, IVDD, MDD, CMDR, JPAL, OSHA, ICH , IEC 60601 and ISO 9000 and 13485 guidelines in manufacturing environments.

• Regulatory/quality knowledge of CAPAs, NCMRs, internal/external auditing, process/ product/software validations, complaint handling and product labeling.

• Experience with Class I, II and III medical devices, pharmaceuticals and all schedules of controlled drugs for humans and animals.

• Effective interface between internal departments, customers, state agencies, FDA, DEA and Notified Bodies such as Intertek, TUV and UL.

• Able to handle multiple projects and maintain quality standards.

• Participated as lead or as a team member in ISO, FDA, DEA, and California FDA inspections.

• Monitor trade publications and FDA website for any changes to regulations.

• Regulatory and advertising knowledge of nutraceuticals and dietary supplements.

Experience

Zest Anchors – Escondido, California (Medical Device – Dental products)

Quality Assurance Manager 10/09 to present

• Management of overall company-wide Quality functions and personnel

• Maintain document control system, CAPA’s, NCMR’s, validations (CNC machines, packaging and testing equipment), design control, internal audits, training program, calibration program, and incoming, in-process and finished goods inspections

• Label, IFU and Technical Manual development for CE marked products

• Quality Management Representative

• Manage 10 employees at two facilities

AVIVA Biosciences – San Diego, California (Laboratory)

Quality Assurance Manager (Laid off) 8/08 to 10/09

• Maintain document control system for procedures, specifications and study protocols

• Preparing company for GLP status

• Review and approve manufactured reagent documents

• Ensure calibration and equipment maintenance program is current

• Perform calibrations on equipment

• Review ion channel testing data for non-GLP clinical studies

• Temperature and humidity monitoring

CUBIC Corporation – San Diego, California (Defense)

Quality Engineer (Temporary Employee) 6/08 to 8/08

• Maintain MRB, NCMR and CAPA systems.

• Provide metric reports on physical inventory of material in MRB and NCMR status for aerospace and defense products.

Provex Technologies, LLC – San Diego, California (Medical Device)

Director of Regulatory Compliance (Laid off ) 3/07 to 2/08

• Create Quality System for a start-up company

• Review and approve all validations, procedures, batch records and promotional materials

• Interacted with FDA and suppliers

• Provide regulatory compliance guidance and policies for product line which consisted of a glucose meter and wound care product for humans and animals

• Perform vendor, laboratory and partner audits

Qualigen Inc. – Carlsbad, California (IVD)

QA/QC/Regulatory Manager 8/06 to 3/07

• Reviewed manufacturing, reagent, and immunoassay analyzer electronic instrument documents and marketing material for in vitro diagnostic kits that tested blood samples.

• Created, reviewed and approved procedures and product specifications

• Filed 510(k) submission

• Conducted GMP training and Management Review meeting

• Reviewed customer complaints and completed investigations

• Maintained approved supplier list, DMR’s, DHR’s and state licenses

• Lead in ISO and FDA audits

• Created and/or approved NCMR’s, CAPA’s and Deviations

• Maintained Illness and Injury Prevention program and conducted safety training

• Technical File maintenance and CE Marking for three new products

• Quality Management Representative

• Managed 4 employees

Ligand Pharmaceuticals Inc. – San Diego, California (Pharmaceuticals)

Government Affairs Compliance Manager 12/04 to 8/06

(Company sold off all products and became a R&D company)

• Audited companies for DEA compliance

• Maintained all state licenses for manufacturing and distribution

• Prepare marketing activity reports for all applicable state agencies

• Maintained Risk Management program for controlled product

• Monitored changes in state laws concerning manufacturing, distribution, and marketing activities (OIG, PhRMA)

• Created audit procedure and work instructions for reporting to state agencies

• Member of BIOCOM, BIO, CHI and participated in a task force on RFID project with several companies and the California Board of Pharmacy.

Applied Biotech, Inc. - San Diego, California (IVD)

Q.A. Specialist (Laid off) 7/04 to 12/04

• Maintained CAPA system

• Conducted GMP training

• Assisted in customer audits

• Reviewed and approved validation packages

• Reviewed labeling and IFU’s for CE marked products,

• Reviewed and approved NCMR’s, technical files, design history files, incoming material specifications and SOP's for lateral flow devices.

Anderson Packaging, Inc.- Rockford, Illinois (Packaging pharmaceuticals)

Q.C. Documentation Supervisor 11/02 to 2/04

• Developed batch records and material specifications with internal and external customers

• Audited packaging batch record documentation for product release

• Developed and maintained departmental work practices

• Assisted with customer audits

• Maintained DEA manual

• Member of several product launch teams

• Lead the Error Reduction Team for documents

• Managed 13 employees across 3 shifts

UDL Laboratories, Inc. - Rockford, Illinois (Packaging pharmaceuticals)

Compliance Officer 2/96 to 11/02

• Conducted GMP training

• Managed Document Control system and re-designed procedure manuals

• Reviewed stability data

• Conducted internal auditing of quality system and documentation with team

• Reviewed material specifications, labeling and packaging batch records

• Developed, reviewed and approved validation packages for materials, software and packaging equipment

• Member of the Safety Committee

• Coordinated destruction of controlled and non-controlled substances

• Conducted environmental monitoring

• Maintained customer complaints system and conducted investigations

• Participated in several FDA and DEA audits

• Managed 2 employees

Abbott Laboratories - Abbott Park, Illinois (IVD)

Quality Engineer for Diagnostics Division 6/92 to 2/96

• Trending of supplier information for supplier ratings

• Created and validated software programs for 21CFR Part 11 compliance

• Coordinated and conducted procedure training

• Maintained CAPA system for supplier issues

• Created and revised procedures

• Audited supplier’s facilities

Abbott Laboratories - Abbott Park, Illinois (IVD)

Incoming Quality Assurance Technician for Diagnostics Division 6/90 to 6/92

• Verified chemicals and blood products.

• Wrote NCMR’s

• Assisted with software validations

Education

Rock Valley College - Rockford, Illinois

Degree Earned: Associates of Science

Barat College - Lake Forest, Illinois

Degree Earned: Bachelor of Arts, Interdisciplinary Studies

Courses Included: Biology, Chemistry, Calculus and Computer Science

Stat-A-Matrix

Certification Earned: Lead Assessor Training for ISO 9000 Standards from Stat-A-Matrix

OSHA 10 Hour Certification Course

Obtained Quality Auditor certification from ASQ in 1999, but have not re-certified.

Member of San Diego Regulatory Affairs Network (SDRAN), Orange County Regulatory Affairs group (OCRA) and Regulatory Affairs Professional Society (RAPS)

Completed study courses for U.S. and International Regulations for certification exam

Contact this candidate