Summary: The main functions of the Sterile Filling Area are to set-up and operate filling/sealing-automated equipment in a clean room environment. In addition clean and sanitize the equipment and areas that are utilized for the filling/sealing operation. Operation occurs in a clean room environment and is governed by strict standards of sterility and regulatory agencies.
The operators in this area aseptically fill parenteral products in liquid and lyophilized (freeze-dried) form, seal the vials, and ensure that Standard Operating Procedures (SOP’s) and current Good Manufacturing Practices (cGMP’s) are followed at all times.
Essential Duties and Responsibilities:
• Comprehend and follow SOP’s, cGMP’s, and good aseptic technique to produce sterile quality products.
• Aseptically assemble and operate automated filling equipment
• Aseptically assemble and operate automated sealing equipment
• Aseptic gowning for various classifications of clean room areas
• Documentation and review of associated paperwork for accuracy and clarity
• In-process inspection or pre-inspection of vials as necessary
• Stock gowning materials for gowning
• Cleaning and sanitization of work areas
• Working with peers to help train each other as directed by Production Management
• Other duties as assigned
This job has no supervisory responsibilities.
Education and/or Experience: High school diploma or general education degree (GED); and 2 year’s related experience (production, manufacturing, and/or clean room experience preferred) and/or training; or equivalent combination of education and experience.
Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Mathematical Skills:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills:
Knowledge of Internet software; Manufacturing software; Spreadsheet software and Word Processing software. Other Skills and Abilities:
• Comprehend and follow SOPs, cGMPs, and detailed instructions to successfully produce sterile quality products.
• Document information, events, and cGMP manufacturing processes clearly, accurately and completely.
• Perform duties in an organized, detail oriented manner.
• Apply basic math: measures, weights, fractions, decimals.
• Apply basic computer skills.
• Work and communicate well with others in a team environment. Other Qualifications: Pass Wonderlic Basic Skills Test at 12th grade level or higher Must be able to obtain and maintain gowning certification Must be able to wear respirator Pass background check Pass drug screen Pass physical
Physical Demands: While performing the duties of this job, the employee is regularly required to talk or hear. The employee is required to stand for long periods of their shift; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly exposed to toxic or caustic chemicals. The employee is frequently exposed to moving mechanical parts; fumes or airborne particles; risk of electrical shock; explosives; risk of radiation and vibration. The employee is occasionally exposed to wet and/or humid conditions; extreme cold and extreme heat. The noise level in the work environment is usually moderate.
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.
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.