Job Description

Renaissance LLC

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Overview

This position supervises the daily activities of union and non-union personnel in the compounding, filling and packaging of sterile and specialty pharmaceutical products in compliance with FDA regulations and cGMP guidelines. Responsible for the proper operation of all production activities assigned, such as, scheduling, training, coaching and counseling. This includes but is not limited to: preparing, staffing and operating production lines, interaction with customers, data collection and interpretation, investigation writing, technical report writing, change control, cleaning and environmental monitoring, and safety.

Responsibilities

• Complete production plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting results on shift production summaries.
• Resolve personnel problems by analyzing data; investigating issues; identifying solutions; recommending action.
• Maintain working relationship with the union by following the terms of the collective bargaining agreement.
• Maintain working relationship with non-union employees in terms of company policy
• Maintain safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
• Ensure efficient operation of equipment by calling for repairs, facility maintenance requests ; evaluating new equipment and processes.
• Contribute to the writing and review of documentation such as SOPs and PRs.
• Assure that all pertinent SOPs are being followed and maintain compliance with cGMPs. Confers with and assists personnel under his/her supervision regarding manufacturing opportunities.
• Participate in developing department goals, objectives, and systems.
• Meet regularly with production personnel to communicate company information and review progress/performance against department goals and action plans.
• Responsible for coordinating communication among production shifts.
• Participate on internal, cross-functional teams to ensure project milestones are met as contracted with our healthcare partners and be accountable for project results.
• Manage and collaborate with all team members regarding operational activities pertaining to the timely and successful execution of all assigned projects.
• Develop creative solutions to technical and organizational problems in order to keep projects on schedule.
• Review, complete and assure implementation of corrective action plans.
• Regularly meet with the Operations Manager to discuss overall project plans, updates, forecasting and potential issues or recommendations.
• Identify and lead efforts to improve processes/systems. Conduct and follow up on continuous improvement efforts such as 6S .
• Self-develop to be able to move into positions of greater responsibility as opportunities occur.
• Perform other duties as required and assigned.

Qualifications

Bachelor\'s degree in the Natural Sciences, Engineering or a related degree with a minimum of three (3) years of relevant experience in the pharmaceutical industry in an Operational role required. A minimum of one (1) year as a group lead or other leadership position is preferred. Other leadership background will be considered ie. Military Service or leadership courses .

PI228287433

Renaissance Lakewood