This description is intended to be illustrative of the major duties performed by the employee assigned to this position. Performs other duties as assigned.
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.
• 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
• 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.