Senior Manager of Inspection and Packaging Operations
10 hours ago
As a Senior Manager of Inspection and Packaging Operations, you will be responsible for overseeing the visual inspection, labeling, and packaging of parenteral pharmaceuticals and dermatological products to meet sales requirements. This role will also involve managing the warehouse shipping and receiving team.
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 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 is 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.
- Other duties as assigned.
- 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.
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
- 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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