Summary:Support timely manufacturing of parenteral cGMP products in an aseptic environment including set up, operating, sanitizing, and sterilizing equipment and manufacturing areas; preparing, washing, and sterilizing vials; complete batch calculations, preparation, and formulations. Sanitize aseptic and controlled areas utilizing specialized solutions and equipment. Perform sterile processing of equipment following sanitization procedures. Complete all sanitization and documentation following Standard Operating Procedures (SOPs).Essential Duties and Responsibilities:
Prepare and sanitize equipment for clean rooms, product compounding, and filling according to the preparation list this includes disassembly/assembly.
Load and unload steam sterilizers, and washers, prepare and weigh stoppers, etc. According to proper diagrams and instructions.
Record all procedures in logbooks following completion and complete/correct batch records to ensure readiness for fill.
Sanitize aseptic/controlled Production areas to ensure microbial contamination is reduced to a safe level on inanimate surfaces.
Bubble point test filters and read/interpret SOPs to ensure compliance.
Other duties may be assigned.
Supervisory Responsibilities This job has no supervisory responsibilities. Education and/or Experience: High school diploma or general education degree (GED); and two years related experience (production, manufacturing, and/or cleanroom experience preferred) and/or training; or equivalent combination of education and experience. Language Skills Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.Mathematical Skills Ability to add, subtract, multiply, and divide into 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 To perform this job successfully, an individual should know Spreadsheet software and Word Processing software.Other Skills and Abilities
Must be able to obtain and maintain gowning certification.
Must be able to wear a respirator
Pass a background check, a drug screen, and a physical.
Other Qualifications
Comprehend and follow SOPs, cGMPs, and detailed instructions to successfully produce sterile quality products. Document information, events, and cGMP manufacturing processes, accurately, and completely.
Perform duties in an organized, detail-oriented manner. Work and communicate well with others in a team environment.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.While performing the duties of this Job, the employee is regularly required to stand. The employee is frequently required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. 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, and depth perception.Work Environment:While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; and risk of radiation and vibration. The noise level in the work environment is usually moderate.All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA 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. Curia is an E-Verify employer.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.