DENISE BERGERON

970-***-**** ac1n36@r.postjobfree.com 2575 Dotsero Court, Loveland, CO 80538

Quality & Supply Chain professional with 10+ years of operations experience in cGMP manufacturing, pharmaceutical and bio instrumentation environments. I am seeking an opportunity to contribute my diverse experience.

KEY SKILLS

QUALITY CONTROL PROCESS IMPROVEMENT DOCUMENT MANAGEMENT PRODUCTION PLANNING TRAINNG INVENTORY MANAGEMENT

ORGANIZATIONAL SKILLS INTERNAL AUDITING VENDOR RELATIONS NEGOTIATION SOP CREATION & EDITING LOGISTICS/SHIPPING PROFESSIONAL EXPERIENCE

Quality Assurance Specialist, St. Renatus, LLC, Ft. Collins, CO 2016-Present

• Report directly to Vice President of Quality Assurance.

• Created, implemented and manage the St. Renatus training program and protocols. Reporting training metrics to executive team on quarterly basis.

• Document Control manager for companywide quality system and implementation of design history file for the Kovanaze product.

• Review current and new vendor approvals and maintain in the Epicor ERP system.

• SOP creation and revisions for QA and SOP document control for all other departments

• Assist with the review of the manufacturing batch records for Kovanaze and responsible for review and release final product batch record for Kovanaze product.

• Assist with product returns, sample requests and performing month end inventory reconciliations across various distribution channels.

• Epicor ERP power user for QA and company trainer.

• Microsoft CRM, managing customer and investor relations data entry. Regulatory Affairs Specialist, St. Renatus, LLC, Ft Collins, CO 2014-2016 Pre-revenue dental pharmaceutical company building infrastructure for commercialization.

• Assist with FDA requests by maintaining appropriate files pertaining to product studies.

• Maintain FDA correspondence log, FDA requests and calls.

• Worked closely with third party vendor, Triligent, to complete the organization of St Renatus’ Trial Master Files (TMF) for all clinical studies; developed strong working relationship with personnel.

• Responsible for the organization of CMC, studies, regulatory and general documents and filing.

• Maintain the Change Notifications that come through from vendors.

• Epicor ERP system implementation and certification. Co-Owner & Office Manager, Snap In Media, LLC, Fort Collins, CO 2008-2014 Family owned business providing web-based marketing solutions for small businesses. Primary responsibility for managing business organization: project staffing, timelines, financial & HR operations and resulting client satisfaction.

• Project management/business operations – project budgets, progress tracking, timeline management for up to a dozen client projects; client relations management.

• Managed the job requirements and performance of 3-5 full time employees and 3-4 interns ensuring client expectations and deadlines were met on time and within project scope and budget.

• Performed monthly audits of accounting transactions and financial reporting via Quickbooks to insure financial data integrity and management.

• Managed business brand presence through social media – Facebook, Twitter, Pinterest, LinkedIn.

• Performed website content maintenance – Word Press. Production Planner, Tolmar Inc., Ft. Collins, CO 2003-2008 Pharmaceutical manufacturing company with products in dermatology, oncology and dental. Joined Tolmar in a newly created Logistics Coordinator role. Over the course of 9 months, they added a significant number of tasks to my role in the area of Backup Production Planning. I used my organizational skills to write procedures and instigated changes to processes to increase operational effectiveness.

• Maintained daily shipping schedule of 19 products; responsible for releasing batch records.

• Maintained planning schedule, held/ran planning meeting(s) with production management ensuring projects were on schedule and I/we could hit shipment dates. DENISE BERGERON - page 2

• When team members, other Production Planner(s) were out of the office, acted a backup production planner for their products in addition to my regular duties.

• Responsible for coordinating the logistics cold chain (temperature sensitive) shipments both locally and internationally; used effective communication skills to ensure successful delivery.

• Researched and provided suggestions to management to consider optional vendors for shipment costs/savings. Cut shipping costs by 15% the first year by improving how our carrier stacked products based on truck size while understanding the air fluctuation.

• Worked closely with warehouse personnel to ensure their proper handling of product according to GMP and ISO standards.

• Worked within the ERP system to generate accurate work orders, notify production management of BOM changes based on product changes and/or packaging etc.

• Released batch records for manufacturing which gave approval to move to the next process.

• As part of my Quality Control duties, worked closely with Doc control on a weekly basis verifying rev control, expirations, etc. making sure signatures were completed on all documents and processes followed.

• As a Tolmar Certified Internal Auditor, I performed ad hoc audits of any departments within the company once every 3 months in which I’d pull SOPs, studies and verify performance of processes. Production Planner, Dako (Acquired by Agilent Technologies), Fort Collins CO 2000-2003 Reagent manufacturing facility where instruments made are used for cancer treatment worldwide. Working within a supply chain team of several hundred people, attended regular supply chain planning and forecasting meetings whose members included Engineers, R&D and Purchasing. I was a member of the Planning Group where my team consisted of 3 other Production Planners each with our own specific product areas.

• Contributed in a 40% inventory reduction going to LEAN manufacturing practices; supported process changes and improved steps in all areas within my control.

• Processed all incoming orders for spare parts, service, new and refurbished instruments.

• Coordinated incoming and outgoing material/orders with warehouse.

• Monitored inventory levels and purchased inventory to ensure necessary availability.

• Created and processed production orders for the manufacturing floor. Followed and monitored EC’s that affected products. Practiced GMP and ISO 9000 standards.

• Performed Min/Tag inventory control and MRP (Oracle) and Agile.

• Certified as an Internal Auditor where I performed ad hoc audits of any departments within the company.

• Employee Recognition Committee Member

• Received Recognition for Point of Quality & Exceptional Performance TRAINING & EDUCATION

Epicor ERP Super User training, St. Renatus, LLC. 2016. MRO purchasing, Dako, 2001-2003.

Business Communication Certificate, Front Range Community College, Fort Collins, CO 1996 American High School, Chicago, IL

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