Summary: The Aseptic Core Monitor will oversees all activities in the aseptic environment to ensure continual compliance with cGMP and provide mentoring on aseptic technique for all aseptic personnel. This position requires expertise in all aspects of aseptic manufacturing of sterile product, ability to work hands on, strong leadership skills, and the ability to collaborate in a cross-functional environment. The individual will work closely with all departments in the manufacturing environment and reports metrics to site management on a regular basis. Essential Duties and Responsibilities:
• Perform daily visual audits of aseptic behavior inside the core during fills, lyophilizer loading/unloading, and sanitization processes.
• Communicate openly to all personnel in the aseptic core to provide feedback and mentoring regarding observed performance.
• Take immediate action when non-compliance and/or undesired behavior by personnel in the facility is observed.
• Provide corrective action training based on visual audits by providing immediate feedback.
• Partner with Operations/Quality/Training Leadership to make recommendations for enhancements to aseptic processes.
• Complete daily inspections of the physical conditions of the aseptic core.
• Review aseptic technique associated with media fills and help complete documentation.
• Presence in the Aseptic Core is required during all manufacturing event.
• Responsible for training personnel in Aseptic Techniques and processes.
• Reports metrics and trends to site management on a regular basis.
• Assumes additional duties and responsibilities as assigned. Supervisory Responsibilities: This job has no supervisory responsibilities
Education and/or Experience
• BS preferably in Microbiology or a related field or equivalent experience.
• At least 3 years industrial GMP experience in an FDA-regulated pharmaceutical environment.
• Aseptic Processing experience, including proficiency in Aseptic Gowning qualifications is desirable.
• The ability to gown and work daily in an aseptic manufacturing environment.
• Proficient in Microsoft Excel, Word, PowerPoint
• Basic quality tools (i.e. pareto charts, histograms, cause-and-effect, root cause analysis) Language/Communication Skills Ability to read, analyze and interpret professional journals, technical procedures, and governmental regulations. Strong written and verbal communication and presentation skills including the ability to independently write develop and write procedures.
Mathematical Skills Ability to calculate formulas and amounts such as: concentration, percentage, area, volume, and proportion. Ability to apply the mathematical concepts from algebra and geometry. Reasoning Ability Ability to solve problems with a variety of variables using past experience. Ability to interpret instructions furnished in written, oral, diagram, or schedule form. Physical Demands While performing the duties of this job, the employee is regularly required to sit; use hands to manipulate, handle, and feel; and able talk and hear. The employee frequently is required to reach with hands and arms. The employee is required to stand; walk; and occasionally required to climb or balance; stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds.
Specific vision abilities required by this job include close vision, and ability to adjust focus. Work Environment While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet. All interested applicants must apply online. AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Note This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities.
To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship. #LI-RG1
To apply for this job please visit pharmaboard.com.