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
