Senior Manager, Inspection and Packaging Operations
4 weeks ago
Job Summary
As a Senior Manager, Inspection and Packaging Operations, you will be responsible for overseeing the visual inspection, labeling, and packaging of parenteral pharmaceuticals and dermatological products. This role requires strong leadership skills, as you will be managing a team of shift leads and floor personnel to improve safety, optimize quality, and elevate performance.
Key Responsibilities
- Directly oversee shift leads and floor personnel to ensure compliance with current Good Manufacturing Practices (cGMPs) and Standard Operation Procedures (SOPs).
- 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 aligns with production goals.
- Assign daily duties to team members to accomplish production goals.
- 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.
- Initiate/Author and 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 timely completion of production goals.
- Make recommendations on efficiency and cost as appropriate.
- Prioritize safety and maintain 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.
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 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.
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
Compensation and Benefits:
The compensation and benefits for this position are competitive and include a base salary range of $130,000 - $142,500, with a bonus target. Employees are eligible to participate in Company employee benefit programs, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, and company match.
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