Jan Warner Ms, Mba Email & Phone Number

New York, Ny, Us

IQA Consulting Services, LLCExecutive of a consulting firm providing quality and compliance services to FDA regulated manufacturers, distributors, companies and suppliers. Programs are tailored for a range of companies, from Fortune 500 corporations to start-ups. Our team of consultants have a range of expertise that comprise: FDA regulated product manufacturing, packaging, Quality Assurance, Laboratory Operations and Regulatory Affairs. Services include:• Creation, implementation and management of Quality Systems for the following standards and regulations: cGMP, ISO 13485, ISO 22716, ISO 15378, ISO 9001, ICH Q7 and EFfCI• Manufacturing, Quality and Complaint investigations• Training, technical writing and SOP development• CAPA and change control management• FDA Field Alerts, 483s, recalls and consent decree remediation• Supplier, API, contract manufacturing and packaging, internal and third party auditing• Full support as a virtual quality/compliance department• Subject Matter Expert for Quality, QC Laboratory and FDA related issuesPartial Client List (for full client list, case studies, and testimonials visit website at: http://www.iqaconsulting.com/expertise.html):SGSProctor and Gamble Co IncJohnson and Johnson Consumer Products Inc.Maquet CardiovascularCroda Inc.Marietta CorporationAbbott Point of CareHenkel Inc.Archer Daniels Midland CorporationAshland Specialty IngredientsCircadia Inc.Iris Beauty Supplies Inc.Lonza Inc.LEKHarrison Specialty Inc.The Monarch Group c/o Swissplas LimitedMcNeil Consumer HealthcareMWVOxygen Development LLCTEVA Pharmaceuticals

Washington, Dc, Us

Wharton, Nj, Us

Leader of quality and regulatory teams for an FDA registered manufacturer, packager and filler of medical devices, OTC drugs, and cosmetics. Responsible for: development of strategic global initiatives to expand resident product lines and meet client-driven business goals; system improvements that continuously meet clients’ rigorous quality needs; oversight of daily output to meet client deadlines; and executive presentations for existing accounts and new business. Clients include over 30 leading global pharmaceutical and cosmetics companies.• Implemented system improvements that drove 28% increase in revenue. Enhancements included: staff re-structuring and training to improve technical proficiency; upgrades and purchases in quality control laboratory and equipment; strategic implementation of electronic controls of material into inventory management software; and HVAC and building upgrades. Improvements allowed for proper control, reconciliation and compliance, resulting in: - a 25% increase in staff productivity and equipment control; - an increase in QA/QC control by over 65% - a 40% increase in product compliance rate• Integrated Quality functions into 21 CFR Part 11 compliant software to expand quality functionality/capability into an existing inventory control system. This increased visibility of quality function to production and planning, allowing for a 65% decrease in shipping time.

Responsible for instituting corporate quality and regulatory operations for medical device, drug, OTC and cosmetics manufacturer. Managed staff, implemented systems, and trained employees to GMP/QSR/Canadian and ISO compliant systems. Led FDA, Health Canada (DIN/NPN) and worldwide regulatory submissions and registrations. Developed metrics and methods for tracking and trending quality system effectiveness. Managed APR, stability, new product quality requirement and quality system documentation.• Coordinated with FDA, Health Canada and other global regulatory bodies to register, manufacture and ship OTC drug/Medical Device products to global market in record time (less than 6 mos).• Increased profitability and productivity by approximately 50%, • Improved reject rates by approximately 35% • Decreased turnaround time by approximately 40%• 0 FDA inspection observations accrued over 1 FDA audit and 1 Health Canada audit.

Us

Responsible for management of GMP, ISO and corporate compliance functions for manufacturer of a transdermal combination product (medical device/pharmaceutical). Rebuilt CMP/QSR compliant structure and systems in less than 7 months. Accountable for upgrading and executing vendor auditing and qualification program. Created SOPs, batch and validation records. Enjoined executive management in quality initiatives. Trained and motivated staff and analytical testing department. Provided guidance for software/hardware validation.

Paris, Fr

Responsible for creation, implementation and management of quality systems and programs and leadership for QA/QC staff. Achieved ISO 9001 certification for facility in 11 months. Instituted collaborative and operational measures to control costs and increase quality for 320 different SKUs and 10 product types. Decreased component rejects by 43% by instituting supplier auditing and monitoring; wrote and implemented 120 SOPs; instituted aggressive measures to reduce scrap rates from 38% to 7% on 11 manufacturing lines.

Mba, Management Of Technology, Total Quality Management

M.S., Management Of Technology

B.S., Biology/Chemistry

Education record