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Manager Quality Assurance

Location:
Beltsville, Maryland, United States
Posted:
October 04, 2016

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Resume:

JERRI MICHELLE SANDERS

***** ****** ****** ************, ** 20866 • 301-***-**** • acww00@r.postjobfree.com

Quality oriented and customer-focused chemical engineer with diversified experience. Experience in regulatory procedures, lab bench work, batch mixing, manufacturing operations and quality control. Extremely competent in dynamic, fast paced environments that demand reduction of costs and increased efficiencies. Initiated production equipment upgrades up to $100K. Managed crews of 30-40 daily and participated in 10+ manufacturing production trials. Acknowledged as an effective communicator and motivator. Experienced with conflict resolution and prevention of grievances with union operatives.

CLEARANCE

DOD Secret Clearance

CERTIFICATIONS

Six Sigma Greenbelt (Villanova University)

RELEVANT WORK EXPERIENCE

Freedom of Information Act Specialist, US Postal Service Headquarters (AINS), Washington, DC

3/2015-present

Processes the full range of relatively complex and time-sensitive FOIA and Privacy Act administrative appeals filed with the Postal Service in accordance with statutory requirements and regulations.

Works closely with officials throughout the Postal Service to identify, obtain, analyze and process for release, records responsive to information requests associated with FOIA and PA appeals.

Analyzes responsive records, conducts research, and prepares responses to assigned FOIA/PA requests, including interim responses or extension letters.

Generates regular workload reports, special status reports, and/or statistical summaries on work activities using automated tracking, workflow or other systems.

FOIA Team Leader & Data Manager, Food & Drug Administration (The McConnell Group), College Park, MD

1/2006-9/2011

Collected and analyzed market data to monitor manufacturers’ compliance with food and cosmetics regulations in the Center for Food Safety and Applied Nutrition (CFSAN) Adverse Events Reporting System (CAERS) database.

Oversaw the life cycle of FOIA requests that pertain to the CFSAN CAERS database, and responsible for updating FOIA team SOP of policy changes and updates.

Communicated weekly with CFSAN Policy Analyst to provide adequate service to requesters and media.

Processed ~2000 dietary supplement adverse events within 1 month to format all future FOIA requests.

Provided QC of 50 case files daily and performed medDRA coding for the CFSAN database.

Became familiar with physician notes, ER charts, autopsies and police reports for FDA reviewers.

Generated monthly reports for FDA program offices to report the CAERS trends and priorities and provided specialized management food, drug, infant formula and cosmetic reports for the FDA Center for Food Safety and Applied Nutrition Officer when requested.

Participated as a subject matter specialist in the onsite evaluation of field activities.

Provided support to agency task forces establishing new or receiving regulations, procedures and programs with national and international impact.

Provided advice and interpretation of legal and regulatory guidelines to representatives or other project stakeholders of a regulated industry, including the Food, Drug and Cosmetic Act (FDCA) and Good Manufacturing Practices (cGMPs) as it relates to drug manufacturing and quality assurance activities.

Documented surveillance and data issues in response to consumer, journalists, industry, and other government inquiries.

Senior Production Quality Supervisor & Engineer, Ecolab Incorporated, Joliet, IL

7/1999-8/2003

Initiated capital engineering projects and production equipment upgrades up to $100K.

Coordinated quality bottle production for all corporate plants.

Directed and trained ~40 specialty operators, production employees, laboratory technicians and batch mixers daily in accordance with safety, GMP and ISO standards.

Supervised production of 260M pounds of liquid product and allocated labor for $1M payroll.

Conducted six (6) audits and Corrective Action and Preventive Action (CAPA) reports monthly.

Aided corporate executives in the launch of Water Care products, meeting all orders within 1 month.

Drafted weekly responses within and outside the agency concerning FDA regulated products.

Identified two (2) corporate ICR formulas that caused extended residency times.

Cooperated on behalf of the Liquids Department with in-house FDA Regulatory Affairs Coordinator to consolidate 2-5 production orders per week and conducted FDA quarterly training for employees.

Recognized as the “Go To” manager for eliminating FDA and batch mixing paperwork errors.

Reorganized stub drums with partial raw and finished materials.

Trained new supervisors.

Designed a bulk filler training program to increase filling efficiencies of new employees by 10%.

Annually completed two total quality improvement projects (TQIPS), one process improvement and one cost savings project.

Ran the specialty order section of Liquids/Organics (MTO) at 102% efficiencies.

Performed 10-30 qualitative and quantitative lab procedures daily to assure quality of batch mixes and bulk filling lines including iodine, specific gravity, pH, absorption, acid-base titration, chloride, sodium, NMR, color, odor, flame, solubility and percent solids tests.

Monitored and approved lab bench work of 20 production employees 2-3 times daily.

Coordinated batch mixing via WonderWare software, analytical lab tests, production planning and packaging of all specialty and small-scale products for national and international customers.

Interacted with formal and informal groups and the general public regarding a range of consumer and biological product safety and availability issues.

Provided advice and interpretation of legal and regulatory guidelines to representatives or other project stakeholders of a regulated industry as it relates to drug manufacturing and quality assurance activities; and negotiating the acceptance of practices and actions to resolve regulatory compliance issues with drug manufacturing and quality assurance policies and practices.

Participated in production trials and identified opportunities to improve batch efficiencies and residency times by modifying raw material ingredients or instructions.

Became the go to for fixing FDA job problems, investigative yield problems, labeling approval, closing open orders and reducing BOM variations.

Successfully calculated raw material adjustments for batch chemical formulas when required.

Applied disciplinary action to production employees within union guidelines when necessary.

Served as integral part of the Water Care products transfer to the Joliet plant.

Personally trained ten (10) blow mold operators and utilities on blow mold bottle machine upgrades and wrote SOP for troubleshooting and implemented blow mold tracking equipment for Joliet bottles.

Proved to be proficient with company lab formulation, adjustments, reduce residency times for batches. Worked closely with lab techs to prevent out of specification (OOS) batches.

Conducted 10 meetings weekly with other team members and plant management to reaffirm production priorities concerning quality, batch mixing, lab tests, bulk filling and small scale order priorities.

Ceramming Quality Supervisor, Corning Incorporated, Martinsburg, WV

7/1997-6/1999

Executed daily allocation of 35-40 employees while monitoring safety and housekeeping.

Led team of ceramming operatives, decal operatives and utilities that inspected 126 million glass items at 93.5% selection rate and re-certified fifty (50) ceramic operatives quarterly.

Lead production of specifications to manage the deployment of materials, parts and processes.

Conducted 4+ ISO audits monthly and reported findings to appropriate plant representatives.

Learned Six Sigma basics for the purpose of improving allocated crew work and safety records.

Provided technical support to colleagues and department head when necessary.

Conducted monthly shift meetings to relay safety and department initiatives to employees.

Optimized kiln car loading and maintained a quality goal of <1800ppm.

Superseded goals of <1800ppm by leading employees with 1206ppm.

Commended by plant management for dealing with difficult people.

Led the other department managers in administrative ad reporting systems.

Kept glass cullet inventory levels down, developed housekeeping initiatives.

Applied disciplinary action to production employees within union guidelines when necessary.

Helped plant engineer with portable cullet system.

Programmed labor distribution spreadsheets for department head and reported monthly production and safety numbers directly to plant manager.

OTHER EMPLOYMENT

Assistant Merchandise Planner, World Duty Free Group (Ultimate Staffing), Bethesda, MD

FOIA Specialist & Mediator, Department of Veterans Affairs (CTR Management), Washington, DC

FOIA Specialist, Environmental Protection Agency (GAP Solutions), Washington, DC

Project Management Analyst III, Federal Aviation Administration (SAIC), Washington, DC

Engineering Technician, Federal Highway Administration (Henderson Associates), Washington, DC

EDUCATION

Carnegie Mellon University; BS Chemical Engineering

University of Illinois at Chicago; Graduate Coursework Chemical Engineering

University of Maryland at College Park; Biological Sciences Coursework

COMPUTER SKILLS

Microsoft Office, FOIAXpress, Input Accel, Adobe Acrobat, Oracle, Business Objects, medDRA code, WonderWare, AutoAudit, WonderWare, MS-DOS and UNIX

AWARDS

McConnell On The Spot Award (2007, 2010), Girl Scout Gold Award, PPG Industries Scholar, Outstanding Employee Safety Records (Corning, Ecolab)

VOLUNTEER ACTIVITIES

Medical Volunteer, Girl Scout Leader, GSCNC Girl Scout Gold Award Panel, National Society of Black Engineers, Carnegie Mellon Alumni Council, Math and Science Tutor



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