Location: Ashland, OH
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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
around the globe. We have 12,000 employees worldwide, with over 3,000 in Customer-facing sales and service roles. Founded as Innovative Medical Technologies in Ohio in 1985, the company was renamed STERIS in 1987. Many of the businesses that have been acquired and integrated into STERIS have much longer operating histories, notably the American Sterilizer Company founded in 1894.
The STERIS Vision is inspired by our Customers' efforts to create a healthier and safer world, and guided by our legacy of leadership and innovation; we strive to be a Great Company. To STERIS, this means we will make a difference by providing world-class product and service solutions for our Customers, safe
and rewarding work for our People, and superior returns for our Shareholders. Position Summary The Associate Scientist I will work within the New Product Development microbiology team with several strains of BSL-1 organisms and employ microbiology methodologies for vaporized hydrogen peroxide (VHP) testing including but not limited to aseptic technique, plate counting, inoculation and recovery of test articles and serial dilutions.
The position will require accurately maintaining, recording and reporting of test data. Additionally, the Associate Scientist I must possess the ability to perform and accurately document tasks according to established work instructions and written protocols
in a timely manner, while working both independently and within a team on multiple studies at different stages of the process.
What You Will Do Carry out assigned projects, laboratory work, and data analysis under the direction of a supervisor. Operate and maintain laboratory equipment. Carry out routine and semi-routine tasks independently. Understand and comply with accepted laboratory and safety procedures. Demonstrate excellent laboratory techniques. Resolve issues using problem solving techniques. Maintain a laboratory notebook and documents laboratory data accurately and timely. Help meet laboratory quality, housekeeping, and regulatory compliance.
Perform all work in a safe and environmentally conscious manner. Complete a basic microbiology skills evaluation prior to beginning any project work. Complete BSL-2 Lab training. Work with different sterilization technologies including vaporized hydrogen peroxide (VHP), liquid chemical, and steam. Complete training and demonstrate solid proficiency of the following: Microbiological techniques including serial dilutions, plate counting and inoculation and recovery of test articles using bacterial spores. Aseptic techniques for use in subculturing/plating of mammalian cell cultures, preparation of microbiological medias/reagents and sterile harvesting.
Use and interpretation of test controls in experiments. Operation of laboratory equipment used in testing. Complete training and demonstrate basic understanding of the following tests: Sterility assurance testing D-value testing Biological and Chemical Indicator testing Critical parameters testing Simulated use testing Microbiology testing required for FDA clearance of a non-traditional sterilizer Population and purity testing for maintenance of bacterial spore stocks What You Need to Be Successful 1-5 years of related microbiology laboratory experience (can include college level laboratory experience).
Bachelor’s degree (B. S. ) in Biology, Microbiology or Molecular Biology is preferred. Cell culture experience preferred. Possess a positive attitude, willingness to learn and be adaptable to changing project needs. Demonstrated experience of working successfully in a team environment. Maintain a level of technical knowledge consistent with current scientific literature and best practices. Comply with established protocols and within regulatory and laboratory requirements. Understand and comply with accepted laboratory and safety procedures.
Independently operate various standard instruments and perform basic maintenance according to established methods. Demonstrate good writing skills for the following: Work Instructions and revisions Test plans/protocols Laboratory reports Out of specification reports Demonstrate good oral communication skills by: Reporting laboratory results to supervisor and team Give presentations to group#LI-MM1What STERIS Offers This is a great opportunity to join a well-established, global company that will invest in your career growth over the long term. STERIS wouldn’t be where it is today without our incredible, talented people.
That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We offer a comprehensive benefits package, including: Competitive pay Annual merit and bonus plans Training and coaching Medical, vision, dental and life insurance 401(k) with a company match Paid vacation time and paid holidays Tuition assistance Opportunities for advancement