Coach, counsel and mentor supervisors throughout the facility’s departments, leading them to achieve their respective goals through accountabilityWorking with materials/warehousing, oversee the daily pull of raw materials and production supplies, managing the workforce and flows appropriatelyCoordinating with materials, assure that the appropriate materials are prepped for clean room entry, according to policies, in a timely and logically sequenced orderScoreboard all production related activities, posting as continuously as possible department, team and individual results as appropriate and beneficialDeliver prepped raw materials and production supplies to the clean room Compounding and AssemblyTogether with Pharmacist in Charge and or Lead Pharmacist, support appropriate compounding operationsManage labeling, sealing and packaging operations.Manage complete production process to assure the completion of finished goods.Meet customer demand through the shipment of product at a rate in excess of 99%. Assure proper balancing of personnel during peak/non-peak days employing multiple strategiesTogether with Materials Manager deliver appropriate inventories to storage through the most effective pick facesContinual audit facility and all processes to assure that a safe environment is always present and that natural ergonomic positioning continually improvesCoordinating with department leads and facility maintenance, guarantee equipment and facility readiness through preventative maintenance and challenge testingWorking with General Manager, participate in daily, monthly, quarterly, etc. financial metrics reviewsReview all waste transactions and opportunities within the facility. Implement improvement plans and strategies together with appropriate departmental leadsWork to ensure the facility is audit ready regarding form, fit and function. Communicating directly with

• Responsible for the daily operations of the batch-staging and/or label-pack areas of the facility.• Schedules and coordinates daily production and picking operations.• Supervises and able to perform the labeling, packaging, and batch staging processes in accordance with standard operating procedures and established policies and methods to meet production commitments.• Responsible for the continuous development of process improvements and efficiencies. • Works on problems of moderate scope where an analysis of the situation or data requires a review of identifiable causes.• Exercises judgment within defined procedures and policies to determine appropriate action. • Acts as advisor to other sub-assembly operations and becomes actively involved as required to meet schedules or resolve problems. • Frequently interacts with human resources, subordinates, outside customers, and functional peer groups at various management levels. • Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules etc.• Provide general or direct supervision to exempt employees and/or skilled non-exempt employees.• Assigns duties, performs employee performance evaluations, and manages conflict and resolution• Works overtime as needed/mandated to complete job tasks.• Ability to manage large groups of people.• Administer corrective actions if needed.• Present daily scheduling information to management on a daily basis.• cGMP (current Good Manufacturing Practices), GDP (Good Documentation Practices), Lean Six Sigma, Root Cause Analysis experienced.

• Verifies and keeps records on incoming and outgoing shipments and prepares items for shipment. Compares identifying information and counts, weighs, or measures items of incoming and outgoing shipments to verify information against bills of lading, invoices, orders, or other records. • Affixes shipping labels on packed cartons or stencils identifying shipping information on cartons, using stenciling equipment. • Unpacks and examines incoming shipments, rejects damaged items, records shortages, and corresponds with management to rectify damages and shortages. • Advanced expertise with SAP, Agile and Prisym.

• Responsible for time reporting including approvals, reporting and tracking attendance according to guidelines. • Schedules employees for assigned cells including overtime assignments, and for maintaining balance in staffing needs across assigned work cells.• Ensures compliance with policies, guidelines and regulatory requirements for self and team.• Conduct and lead regular and ongoing team meetings (Example: Tier 3 meeting with extended support team)• Ensures value stream is hitting production metrics and drives corrective action to correct if needed. • Investigate root cause of non-conformances, identify and execute corrective actions by expected completion date. • Responsible for performance management and timely delivery of disciplinary actions.• Ensures safety of employees by proactively identifying safety concerns and resolving open incidents in a timely manner (EHS incidents). • Monitors quality of products according to established standard procedures through all phases of production processes.• Implements improvement as it pertains to quality, setups, operations, and system procedures, while accurately documenting problems and solutions.• Monitors the quality, efficiency, and effectiveness of assigned personnel and overall manufacturing performance and associated metrics within their department.• Works with the Planning Department as needed by providing feedback regarding the workload to ensure maximum throughput of products.• Assigns appropriate personnel to production operations as required.• Responsible for the cleanliness and organization of the department. This could include material control, product hold issues, scrap discrepancies, etc.• Actively implements departmental training programs on an on-going basis. Reviews progress with each operator in training.• Participates in cross-functional supervisor meetings.

• Participate in continuous improvement activities to improve product quality, reduce manufacturing costs, and reduce manufacturing process cycle time.• Assist in engineering change requires process by submitting and tracking the changes.• Maintain and update forms, tracking sheets and requests related to engineering group, projects and meetings.• Design processes to enhance work flow.• Assist in the preparation/writing SOP’s.

• Perform inspection of products as assigned. Maintain appropriate records for all inspection activities as described in MSB procedures.• Maintain Quarantine inventory both physically and systematically as required. • Review nonconforming product returns daily. Enter information into GCH database and make appropriate inventory transfers in SAP as required. • Complete and maintain all Quality records in accordance with the good documentation practices outlined in MSB procedures.• Support Global Quality staff with activities related to quality issue verification, Product Hold Orders, and product quarantine.• Proficiency with SAP warehouse management including item transfers, transfer order creation, item inquiry, and item history.

• Functions in uncommon situations.• Have a basic understanding of stress response and methods to ensure personal well-being.• Have an understanding of body substance isolation.• Understand basic medical-legal principles.• Function within the scope of care as defined by state, regional and local regulatory agencies.

• Prepares work to be accomplished by studying assembly instructions, blueprint specifications, and parts lists; gathering parts, subassemblies, tools, and materials.• Assembles components by examining connections for correct fit; fastening parts and subassemblies.• Resolves assembly problems by altering dimensions to meet specifications; notifying supervisor to obtain additional resources.• Maintains supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.

• Prepares work to be accomplished by studying assembly instructions, blueprint specifications, and parts lists; gathering parts, subassemblies, tools, and materials.• Assembles components by examining connections for correct fit; fastening parts and subassemblies.• Resolves assembly problems by altering dimensions to meet specifications; notifying supervisor to obtain additional resources.• Maintains supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.

• Reviewed WMS reports; notified WMS personnel regarding shutdowns or other WMS failures.• Initiated improvements in production and recordkeeping that was implemented throughout the plant.• Utilized Standard Operating Procedures to resolve and correct problems; communicated issues to Inbound/Outbound Manager.• Utilized Productivity Improvement Plan process to identify improvement areas.• Reviewed reports to determine daily department staffing levels; reviewed staffing plan with Inbound/Outbound Manager.

• Conducted careful inspections of finished cloth for passenger seats in Nissan vehicles.• Documented any defects in cloths, trends in products and damaged materials.• Trained new employees on proper inspection procedures and typical product errors.

• Installed necessary parts on finished BMW seats prior to shipping.• Oversaw production of seven machines adding parts to seats.• Successfully attained hourly production quotas during each shift.• Set-up, adjust, and record machine parameters per standing operating procedures• Perform record keeper duties consisting of data entry, transfer of employees, and reporting hours, etc. in the absence of supervisor and Production Technician• Perform Production Technician back-up duties and assignments• Understand and follow all SOPs, GMPs, and safety regulations• Use specifications, Bill of Materials, and SOPs to ensure product acceptability• Document process abnormalities, report to supervisor and quality and take corrective actions• Complete all production records and review all batch documentation for completion• Perform change-overs, line clearances, material movement, inventory management, etc.• Communicate with department employees, management, engineering and maintenance• Perform 6S assigned responsibilities

• Oversaw production of IV bags by machines prior to shipping to customers.• Maintained accurate records of production delays and machine errors.• Conducted product inspections and ensured completed orders were labeled for shipping.• Worked in high volume medical production facility.• Develop detailed operational understanding of all department equipment• Operate, perform machine adjustments and maintain all department equipment• Participate and assist in the training of new personnel• Complete required training programs• Participate in ongoing review of procedures and training materials• Participate in continuous improvement efforts and lead projects, meeting all timelines• Assist with the analysis/trending of performance data such as scrap, rework, etc.• Run Label Machine per procedure• Assist in stack-off to maintain steady flow of bottles on all conveyors• Perform all other duties and responsibilities as determined by supervision/management