Inspection and Packaging and Warehousing Manager

Job Summary

Execute plans, schedule, and expedites the visual inspection, labeling and packaging of parenteral pharmaceutical along with dermatological products to meet sales requirements according to current Good Manufacturing Practices (cGMPs) and following Standard Operation Procedures (SOPs).This position will also manage the warehouse shipping/receiving team.

Area Of Responsibility

• Directly oversee shift leads and floor personnel through regular presence on the floor in the inspection/packaging areas as well as the warehouse to improve safety, optimize quality and elevate performance.
• Manage all kit inspection, packaging and labeling operations in accordance with direction from the Operations Director and commercial forecast.
• Plan, Lead, manage, prioritize and organize work in the ILP and warehouse operations teams.
• Work cohesively with the Sr. Production manager to ensure packaging area scheduling are in alignment.
• Able to be a SME for Visual Inspection during FDA/Health Canada/EU inspections.
• Assign daily duties to group to accomplish production goals utilizing personnel effectively.
• Ensure all staff training and qualifications for Visual Inspection are up to date.
• Resolve routine to complex inspection and packaging issues and/or equipment problems with staff and/or other departments in a timely fashion
• Revise batch records and standard operating procedures (SOP's) as needed to improve efficiency and quality of manufacturing/packaging process
• Use systems like SAP, Track-Wise, EDMS and Master Control etc.
• Initiate/Author and be able to complete Deviations, Change Control, CAPA's etc.
• Update computer data for packaging department to record production inventory, results, dates, problems, etc.
• Review all in-process documentation for accuracy
• Ensure proper operation of Inspection/Labeling/Packaging equipment
• Plan and order supplies for production to assure the timely completion of production goals
• Make recommendations on efficiency and cost as appropriate
• Work under minimal direct supervision, utilizing some standard procedures along with own judgment
• Prioritizes safety and maintains good housekeeping in the ILP working area and warehouse.
• Oversee all phases of the Change Control process for owned changes
• Hire, train, manage and motivate staff to meet production and warehouse demands
• Other duties as assigned

Work Conditions:

• Office
• Shop/Shipping area
• Controlled/Manufacturing area

Physical Requirements:

• Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
• Climb or balance, stoop, kneel, crouch or crawl, talk or hear, taste or smell
• Close, color and peripheral vision, depth perceptions, ability to adjust focus
• Correctable 20/20 vision
• Ability to visually inspect small products and print
• Be able to multitask
• Operate label application machinery, thermal transfer printer, computer, serialization and heat sealing equipment
• Operate computer/office machines
• Proper gowning, Safety shoes, safety glasses, gloves
• Lift up to 30 lbs.

Travel Estimate

Up to 5%

Education and Job Qualification

• B.S. required
• Must possess current, valid class D Driver's license
• Ability to operate and maintain all process equipment
• Familiarity with FDA cGMP, SOPs and ISO standards
• Knowledge of pharmaceutical labeling/packaging equipment and warehouse operations

Experience

• Minimum 8-10 years related experience with minimum 4- 6 years in a supervisory and/or managerial role required
• Direct experience with manual visual inspection for small volume parenteral required
• Strong computer skills