PRODUCTION LEAD:
This description is intended to be illustrative of the major duties performed by the employee assigned to this position. Performs other duties as assigned.
GENERAL DESCRIPTION:
This position reports directly to the Production or Formulation Supervisor as well as the Manufacturing Manager. The role is responsible for general support of the Sterile Compounding Area.
ESSENTIAL FUNCTIONS:
• Assist Production/Formulation supervisor in overseeing employees who are responsible for formulation or aseptic filling of sterile ophthalmic and injectable solutions, including space and hood preparation.
• Collaborate with Production Supervisors to ensure completion of Formulation/Filling of products to meet scheduled release dates.
• Provide strong people leadership with a focus on creating/maintaining a positive work environment through effective communication, performance management, accountability, etc.
• Ensure training on SOPs and processes remains current.
• Analyze Production efficiencies downtime and waste.
• Write investigations and CAPA actions for non-conformances in the department. Work with QA to quickly resolve any variance or document errors so that product may be released on time. Lead Problem Solving activities.
• Manage daily staffing.
• Able to lift up to 50 lbs. and stand for extended periods when required

SUPERVISORY RESPONSIBILITIES:
• Supervision of employees is required

EXPERIENCE AND NECESSARY SKILLS:
• 1-year previous leadership experience or comparable experience preferred.
• Minimum 1 years’ experience in aseptic processing preferred.
• Knowledge of cGMP guidelines/standards.
• Bachelor’s degree or relevant experience.
• Demonstrated written and oral communications skills including strong presentation skills.
• Excellent organizational skills and results oriented.
• Strong results orientation.
• Strong Microsoft Office skills are essential, proficient in the use of spreadsheets and word processing programs
• Negotiation and ability to effectively bring others together and reconcile differences.

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