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Grand River Aseptic Manufacturing, Inc Aseptic Manufacturing Supervisor in Grand Rapids, Michigan

DescriptionJOB SUMMARYManage routine manufacturing tasks under the guidelines of established procedures and cGMP regulations under guidance of senior management and provide leadership to other employees.ESSENTIAL DUTIES & RESPONSIBILITIESManage routine manufacturing activities; including day to day scheduling and resource management.Provide leadership when performing component and equipment preparation, bulk drug formulation, aseptic formulation, and aseptic filling duties as needed.Accurately document data and complete batch records as needed.Successfully complete facility's gowning and manufacturing qualification program.Perform and train other employees in various manufacturing tasks, including, but not limited to: fill/finish, lyophilization, gowning, sanitization, and component and equipment preparation activities.Operate production equipment.Perform and assist in the development of formulation activities.Perform duties in Grade C cleanrooms and Grade A isolators.Execute and author well-defined procedures and assist other technical personnel on issues and problems.Initiate revisions to cGMProcedure guidelines.Assist in the scheduling and performance of routine maintenance of production equipment.Oversee operations of the production areas, including the warehouse and utility areas.Participate in client communications, including problem solving, schedule development, and project status updates.Perform routine performance assessments with direct reports.Define and uphold disciplinary actions for poor performance of direct reports, as necessary.Foster a positive team environment that promotes productivity and employee satisfactionSupport Agency, customer and vendor audits as needed.Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.Perform all other tasks, projects, and duties as assigned.RequirementsDESIRED SKILLS & ABILITIESPrior GMP sterile manufacturing experience preferred.Professional and positive approach.Proven leadership skills.Self-motivated.Ability to follow procedures and regulatory guidance documents.Strong in building relationships and able to communicate at all levels.Team player, and able to work on own initiative.Proficiency in both written and verbal communication and presentations.Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.Results oriented and efficient.Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.Ability to work closely with a diverse customer base (internally and externally).Ability to work well in a cross-functional team environment.Must have proficient computer skills in Microsoft Word, Excel and Outlook.Qualified candidates have a Bachelor's degree in life sciences or equivalent training and/or experience. Two to five (2-5) years of relevant experience in pharmaceutical manufacturing or a laboratory environment is required. Previous leadership preferred. Available for off-shift and/or on-call work, as needed.GRAM supports Equal Opportunity Employment