Inspection and Packaging Operations Manager
2 days ago
As a key member of our team at Wimmer Solutions, you will be responsible for overseeing the visual inspection, labeling, and packaging of parenteral pharmaceutical and dermatological products. This role requires a strong understanding of current Good Manufacturing Practices (cGMPs) and Standard Operation Procedures (SOPs). You will also manage the warehouse shipping/receiving team and ensure that all staff training and qualifications for Visual Inspection are up to date.
Key Responsibilities- Directly oversee shift leads and floor personnel 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.
- 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.
- Office
- Shop/Shipping area
- Controlled/Manufacturing area
- 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 perception, 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.
- 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
- 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
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