Karen Alexander Email & Phone Number

Columbus, Ga, Us

Management, training and development of the Regulatory and Documentation staffs (7 employees).Implementation of new Regulatory & Documentation policies and procedures.Implementation of Corporate policies for product labeling and advertising / promotional materials.Implementation of processes which have reduced turn-around-time for label reviews by 20%.Work with R&D and Marketing departments to facilitate development & launch of new products.

Upgraded the Quality System to achieve ISO 13485:2003 registration.Management and training of the QA, QE, QC and RA staffs.Management Representative for the Quality System.Development and implementation of Quality System (21 CFR Part 820 and ISO 13485) procedures and programs.Domestic and foreign registrations and new device submissions.

Management, training and development of personnel performing microbiological testing for medical device, drug, textile & tissue banking industries.Development of custom studies for sterilization, re-use & environmental control programs.Ensured compliance with 21 CFR Parts 211, 820, ISO 9001 & ISO 17025.Implemented a process-improvement program that reduced turn-around-times by up to 30%.Internal, supplier and contract auditing.Provided quality and regulatory consulting to medical device and tissue banking clients which included development of various 510(k)’s, auditing of facilities, development of corrective action plans and communications with regulatory agencies throughout the world.

Performed third party audits for companies seeking ISO 9001/9002, EN 46001/46002 and CE marking registrations.Determined suitability of Quality Systems and overall compliance to the standards and Medical Device Directive.Conducted assessments of a variety of medical device manufacturer’s in the US, Canada, Mexico and Puerto Rico.Conducted specialty assessments for sterile products to ensure compliance with ISO 11134, ISO 11135 or 11137 standards.Conducted specialty assessment for products having initiated or completed clinical evaluations.Approved or denied certification and CE marking of medical device and combination products.

Management, scheduling, development and training of a staff of 12 microbiologists.Ensured department compliance with FDA, CLIA, State of Georgia, ISO 9001 and EN 46001 requirements.Developed & implemented procedures and validation programs for chemical, EO and steam sterilization processes.Worked with manufacturing to optimize processes and to troubleshoot process deviations.

Management and training of staff performing QC and research functions for the food, drug, cosmetic and IVD industries.Ensured department compliance to GMPs.Worked with manufacturing to identify and correct process deviations and to increase product yield.Performed internal audits of the manufacturing and quality control processes.Researched and determined corrective actions to salvage approximately $750,000 worth of nonconforming product per year.Worked with Corporate facility in the Netherlands to ensure consistency in methods and processes between the facilities and initiation of Corporate HAACP program.Investigated and responded to quality-related customer complaints.

Bs, Biology

Aas, Medical Laboratory Technology

State University of New York at Canton