Operations Manager

Bridget Huff

**** ****** **, ********, ** *****

513-***-**** • adhp4m@r.postjobfree.com

Education Miami University Oxford, OH

·Bachelor’s Degree in Integrated Studies

·Associates of Applied Business

·Certificate in General Supervision

·Certificate in Small Office Management

Work Experience Feb 2015 – Sep 2020 Aprecia Pharmaceuticals, LLC Blue Ash, OH

Operations Manager

·Assistant Manager - Operations Engineering (Feb 2015 - Jul 2019)

·Effectively manage the Warehouse Manager and Buyer by managing warehouse operations and purchasing of raw materials, components, and in-process goods

·Manage the purchase order process from creation, approval, execution, and receipt of goods. Follow up with vendors when needed to ensure materials are on time.

·Develop policies and procedure in the area of planning, procurement, inventory control, receiving, storage, and distribution throughout supply chain

·Evaluate best price, quality, availability, and reliability when purchasing materials and interface directly with all departments in regards to materials

·Track and negotiate agreements/contracts with vendors, i.e, cost, scope of work, and contract term length

·Prepare and manage GMP product shipments to 3rd party packaging contractor and distribution warehouse by maintaining product integrity throughout the shipment with dedicated temperature controlled trucks

·Manage the Perpetual Inventory Spreadsheet for raw material, packaging components, and finished goods

·Manage/monitor inventory levels, materials expiry dates and order materials based on production forecast

·Manage vendor relationship and point of contact for vendors for purchase orders, pricing, contracts, and/or material quality concerns

·Audit inventory transactions on Inventory Control Sheets for accuracy and completeness

·Ensure raw materials and packaging components stay within 5% during reconciliation

·Collaborate with Production Management for issuance of production batch records and staging materials based on the production schedule

·Lead the quarterly inventory counts for reconciliation and inventory tracking

·Establish and deliver on Supply Chain and Operations Engineering goals and metrics

·Project leader for the implementation and qualification of new Computerized Maintenance Management System (CMMS). CMMS Subject Matter Expert for day-to-day operation, maintenance, and training.

·Coordinate and track training for new department personnel and outside contractors

·Provide asset management for incoming assets at the Blue Ash facility

·Schedule work orders and preventive maintenance for GMP and non-GMP equipment for Facility/Production Maintenance Technicians

·Create/revise Operations Engineering controlled GMP documents including Maintenance Task Lists, Operations Engineering SOPs, Policies and Calibration reports

·Assist with the qualification of GMP equipment and/or complete final review of executed protocol and complete periodic validation reviews on qualified GMP equipment

·Approve invoices and track department budgets

·Conduct Administrative responsibilities including, but not limited to, quarterly metric reporting, maintain department vacation schedule, and maintain department filing system

·Initiate Change Controls and Deviations for various projects and provide supporting documentation to meet project deadlines

2010 – 2015 Allergan (formally Forest Pharmaceuticals) Cincinnati, OH

Supervisor, Facilities Services

·Technical Specialist, Facilities (June 2013 – April 2014)

·Administrative Assistant to Facilities and Engineering (July 2010 – June 2013)

·Temporary-to-hire employee through Staffmark (July 2010 – February 2011)

·Ability to follow cGMP procedures and report on deviations as necessary by research and working with other departments to establish root cause

·Supervise and maintain schedules/tasks for janitorial department and outside contractors

·Prepare and distribute project status reports, departmental metrics, and resource utilization metrics/spreadsheets

·Deviation investigation, reporting and on-time closure using TrackWise Quality System

·Change Control initiation / data gathering, summary reporting and on-time closure

·CAPA initiation / data gathering / follow-up, response generation and on-time closure

·Documentation auditing for errors and follow up with proper corrections

·Order materials, parts, and machinery to support department and site by obtaining quotes and place orders using company credit card and SRM portal for Purchase Order submittal

·Participate in creating departmental budgets and tracking budgets on quarterly basis

·Create and submit Capital Order Requests for the Facilities and Engineering departments

·Support various projects by processing proposals/contracts, following project budgets and costs, and ensuring on time delivery to meet project deadlines by maintaining relationships with vendors

·Reconcile monthly credit card purchases with Cost Centers and GL accounts while tracking budget balances

·Contact and schedule external contractors for various projects and/or maintenance

·Document Control Administrator - assist in maintaining Documentum Compliance Manager for controlled documents (SOPs, Forms, VMPs, and Reports for review and approval)

·Assisted with the implementation and qualification of new Computerized Maintenance Management System (CMMS)

·Preparing and closing work orders and maintaining assets in the CMMS

·Coordinate and execute Validation and Facilities SOP training

·Enter SOP and Protocol training into the Forest Learning Center (FLC) training database

·Card Access Administration - create and issue badge access and prepare monthly reports

2005 – 2009 Pole/Zero Corp West Chester, OH

Engineering Document Control Clerk

·Maintain and control Macola, a database used to track and store all inventory items purchased and/or produced at Pole/Zero

·Control all original Engineering documents, including Engineering drawings, bills of materials, and Engineering Change Notices (ECN’s)

·Responsible for auditing Engineering Change Notices (ECN’s) incorporated documentation including CAD drawings and bill of materials

·Load and update Engineering bills of materials and exporting parts list to a .PDF format for incorporation

·Maintain the Pole/Zero MRP system by making sure that all data is kept current

·Maintain Configuration Data files which contain Pole/Zero part numbers for each Military program

·Responsible for updating Configuration Summaries for customers including, Boeing, Northrop Grumman, and Lockheed Martin

·Worked with team that implemented a new IFS application. Helped with data migration and testing new system software and capabilities, as well as writing new procedures and training material

References Ted Kremer 513-***-**** Sr. Dir. of Pharmaceutical Operations

Angie Stewart 513-***-**** Vice President of Quality Assurance

Bill Hall 513-***-**** Director of Engineering

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