Aseptic Operator I - Night Shift, 12 Hours
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Would you like to join an award winning organization that is dedicated to saving lives?
In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.
Is that you? If so, we want to learn more about you!
Our Bedford, OH facility is seeking an Aseptic Operator I who performs a variety of operations that support the aseptic filling processes, primarily the highly automated component preparation equipment such as autoclaves, parts washers, and frame washers. This operator’s duties include at minimum material transfer through multiple classified and controlled production areas, room sanitization/disinfection, the management of parts and the loading of those parts into equipment for cleaning and sterilization. The operator must follow Standard Operating Procedures (SOPs), Good Documentation Practices (GDocP) and current Good Manufacturing Practices (cGMPs). This position requires integrity, understanding of the equipment, understanding of the procedures that control the operation of that equipment, and following the working requirements for Controlled Non-Classified, Classification D, and Classification C cleanrooms designed to prevent the introduction or spread of contaminants in manufacturing spaces.
Key Responsibilities
- Safe loading, unloading, cleaning, and operation of sterilizing autoclaves
- Safe loading, unloading, cleaning, and operation of parts washers
- Safe loading, unloading, cleaning, and operation of frame washer
- Safe operation of Clean-Out-of-Place (COP) washing sinks
- Safe dispensing of raw materials used for compounding and creation of product
- Cleaning and disinfection of Grade C&D spaces and equipment
- Complete all required training. Ensure that training is completed prior to performing any activity
- Perform job functions while maintaining compliance with 21CFR part 210 and 211, FDA, OSHA, and other regulatory agencies.
- Ensure that requirements for Environmental, Health, Safety (EHS) are met.
- Documents all work accurately and in a timely manner. Self-monitors and reviews all documentation for completeness and accuracy.
- Reconciles components and product ensuring batch accountability.
- Any other duties as directed by Production Management.
- Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies.
- Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
Experience and Skills
- Required:
- HS Diploma/GED
- Preferred:
- Associates Degree
- 0-3 years of related work experience in a cGMP environment / or cGMP trade certificate.
- General computer skills proficiency
- Military service highly desirable
We offer a competitive compensation and benefits package with an excellent working environment that is safe and engaging. Leaders are dedicated to your success and support professional and personal growth through various development and training opportunities. If you are looking for a rewarding career, Xellia is the organization for you!
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here
Information og data
Denne ledige stilling har jobtypen "Laborant", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.
- Laborant
- København
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