Lead Monistat Production Tech - 1st Shift

• Ensure equipment readiness, minimize downtime, and suggest equipment improvements to drive OEE improvements and support efficient production demands.
• Perform periodic reviews with maintenance staff of the OEE tracking system to ensure full functionality and cGMP compliance.
• Drives decisions and owns responsibility to meeting schedule commitments

• Assist in the planning and scheduling of commercial batches
• Lead and assist in the successful manufacturing of commercial and full-scale validation batches
• Maintain the inventory system for raw materials and primary packaging components
• Troubleshoot, diagnose, and repair machine breakdowns if maintenance support is not required
• Assist in decisions on equipment selection, purchases, and processes
• Lead team in the set-up and change-over of production and primary packaging equipment
• Ensure manufacturing area and equipment are maintained in accordance with company and regulatory requirements
• Recognize potential problems and provide input on corrective action
• Lead & assist in training staff for Cream Production and Primary Packaging
• Identify and resolve process and/or equipment failures; initiate appropriate action to prevent recurrence
• Maintain machines to ensure that SOP’s and Work Instructions are adhered to, and quality product is provided according to all cGMP documentation.
• Responsible to maintain work area in a safe, clean and orderly condition according to cGMP documentation.
• Lead in the execution of validation protocols as they pertain to batching and/or equipment qualifications
• Assume operational control of the department to the extent required in the absence of departmental management.
• Provide technical guidance and training to personnel as required.
• Writes and updates SOP’s and Work Instructions for the areas assigned.
• Perform other related duties as required

• Position requires the ability to lift in excess of 50 lbs unassisted
• Majority of workday is performed while standing, walking, lifting, pulling, pushing
• Requires the ability community effectively using speech, vision and hearing
• Requires the use of hands for simple grasping and fine manipulations
• Requires bending, squatting, reaching, pushing, climbing
• Requires the ability to stand for extended periods of time
• Some exposure to hazardous chemical and other active chemical ingredients
• Must be able to work in a team environment
• Must be able to use a variety of tools, equipment, and machinery

• High school diploma or equivalent with at least six years of equivalent pharmaceutical industry experience
• Associate’s degree with at least four years of equivalent pharmaceutical industry experience
• Bachelor’s degree (scientific degree preferred) with at least two years of relevant experience
• Experience in an FDA regulated industry and a thorough functional understanding of pharmaceutical manufacturing processes and cGMPs

• The start of a great career working with a diverse group of great people
• The health and safety of every employee... our top priority
• A clean, air-conditioned cGMP environment
• Top notch benefits –paid time off, 401(K) retirement savings with company match, medical, dental and vision, pay annual targeted bonus, competitive pay, life insurance, Flexible spending account, and tuition reimbursement.
• Stability – a record of strong financial performance and part of a growing $1billion company
• A business supporting the Lynchburg community for over 150 years.

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