Nurse manager, dahms clinical research unit

inspection of safe and effective sterile (injectable) medical products.

Operation of secondary packaging line equipment, labelling, and equipment cleaning. Interacts with Quality, Technical Services, Maintenance, Warehouse Departments, and other departments as required.

Ensures that daily production is carried out according to current SOP's ensuring absolute compliance to quality standards. The Operator is responsible for documenting daily production outputs and efficiencies and keeps other stakeholders involved and informed. Challenges during production are documented and resolved by means of various LEAN tools. Collaborates in the training of colleagues. Key Responsibilities:

Set-up, operation, and troubleshooting of manufacturing equipment: including (but not limited to) Manual Inspection Booths, Semi-Automated Inspection Machine, Secondary Packaging Machines and ancillary equipment (conveyors, pallet jacks, etc.

) within validated parameters and in compliance with c GMP's. Operation of automated equipment through a Human Machine Interface (HMI). Clear and concise written documentation to support GMP activities. Performs line change overs and simple-to-moderate equipment adjustments. Supports the creation and updating of procedures enabling the improvement of quality, compliance, and overall process performance. React to issues on the production line

and start up systematic problem-solving enabling colleagues to support root cause analysis.

Adhere to c GMP's, SOP's, Batch Record processing steps, and site environmental and safety policies. Support a continuous improvement culture and mind set within the department. Possess strong commitment to quality and compliance. Guide colleagues in the importance of proactive behavior regarding improving the work environment towards zero accidents. Work closely together with quality to solve quality issues as they occur and ensure timely release of products. Responsible for execution and completion of individual Training per required curriculum. 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, c GMP's, FDA, OSHA and other regulatory agencies. Requirements: High School Diploma or GED; Associates Degree in a natural science or technical curriculum preferred Prior experience in a regulated environment; medical or medical device manufacturing experience preferred Must be able to learn and develop a working knowledge of c GMP's; previous knowledge of c GMP requirements preferred Prior experience with complex high speed packaging equipment Experience with quality control technology including vision, robots or automation preferred Ability to clearly read and write English Demonstrates a strong desire to continuously learn and improve 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. Candidate will not be permitted to wear (in the classified manufacturing areas) jewelry, makeup, hair extension, or any exterior adornment (religious articles will be evaluated on a case-by-case basis as to backss impact on controlled environment and drug product). Physical Requirements of the Role: Adequate vision required, must be able to successfully pass visual acuity requirements (20/20 corrected vision, distinguish colors as required. Visual Acuity requirements are tested annually).

Ability to stand, sit, and/or walk for long period of time. Ability to operate material handling equipment. Ability to lift, push, and/or pull up to 50 lbs frequently. Position requires continuous standing and walking. Must be able to be gown qualified. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may affect the safety or quality of a drug product shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products.

All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products. #LI-AH1#LI-Onsite Xellia medicals is owned by Novo Holding A/S and is a specialty medical 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 medicals here

supervise, coordinate, and control the activities of facilities operation, transportation, security and environmental services and security staff and contractors. Create and manage policies addressing a safe environment for patients and the reporting of safety concerns.

Manage all areas of responsibility effectively within budgetary guidelines by monitoring and controlling costs and ensuring quality completion of projects. Ensure the effective preventative maintenance calendar for buildings and vehicle fleet and make sure all items and duties are carried out. Research and resolve problems related to facilities operational issues. Conduct facility inspections and manage inspection results

and repairs. Ensure the necessary programs are in place to guarantee plumbing, electrical systems, carpentry, roofing, mechanics, masonry, HVAC and generators are all maintained and working properly.

Participate in completing maintenance tasks if and when needed. Obtain service quotes and coordinate vendor services and synchronize projects. Work in conjunction with all appropriate agencies to ensure proper emergency protocols/procedures are established and followed. Coordinate workplace adjustments as needed, physical moves of furniture & equipment. Manage outsourced building services including (but not limited to) janitorial, grounds maintenance, security, and garbage collection. Performs

quality control inspections to ensure adherence to contract specifications and industry standards.

Lead the Safety committee and manage initiatives. Make sure all facilities and safety HRSA, OSV and Joint Commission requirements are met. Maintain all required records including maintenance contracts, inspection reports, insurance documents, and permits. Manage the physical maintenance of all vehicles, this includes repair and preventative maintenance of all vehicles, owned, or leased. Supervise the transportation department, making sure all drivers are properly and compliantly trained per our policies and procedures. Oversee the building alarm system and respond to safety alarms and calls from the security system vendor and/or police and fire department calls.

This also includes resolving issues as appropriate and reporting incidents to senior management. Conduct regularly scheduled safety drills for staff and training as required and appropriate. Lead the creation and execution of emergency preparedness plans and safety initiatives. Requirements: Minimum Education and Experience: Required: Associate degree (A. A. ) or equivalent from two-year college or technical school; and five years related experience supervising in this field; or equivalent combination of education and experience.

Minimum of 5 years' experience implementing procedures, safety measures and commonly used concepts and practices required to manage multiple healthcare facilities. Good basic computer skills (email, Microsoft Office and work tickets) are essential. Possess strong mechanical aptitude and have experience in electrical, plumbing, carpentry, pumps, HVAC, lock repair, etc. Valid driver's license with less than 6 points JCAHO experience a plus Experience in ambulatory clinics, hospitals and/or healthcare facilities a major plus Technology Requirements: Basic understanding and familiarity with the following: Basic computer knowledge Spreadsheet software – Ex: Microsoft Excel Microsoft Software – Ex: Microsoft Word (word processing technology) Minimum Education and Experience: Required: Associate degree (A.

A. ) or equivalent from two-year college or technical school; and five years related experience supervising in this field; or equivalent combination of education and experience. Minimum of 5 years' experience implementing procedures, safety measures and commonly used concepts and practices required to manage multiple healthcare facilities.

Good basic computer skills (email, Microsoft Office and work tickets) are essential. Possess strong mechanical aptitude and have experience in electrical, plumbing, carpentry, pumps, HVAC, lock repair, etc. Valid driver's license with less than 6 points JCAHO experience a plus Experience in ambulatory clinics, hospitals and/or healthcare facilities a major plus Technology PIc95ef0af For more details: jobs-search. org/facilities-manager_cleveland-c443443/facilities-manager-cleveland_i1973366196