Microbiologist
Coloplast Corp. - Minneapolis, MN
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Microbiologist Location: Minneapolis, MN, US Job Family: Quality Assurance Country/Region: United States The Microbiology, Microbiologist is responsible for performing all tasks to support the Microbiology Lab in IU Global Operations. This position ensures that good microbiology techniques and policies are followed, and provides Microbiology support to the Value Stream and Research & Development. Major Areas of Accountability Aids in establishing, implementing, and improving of best practices for meeting FDA, ISO and Coloplast requirements with respect to product sterility assurance and microbiology testing. Plan and coordinate laboratory support functions for routine finished product release and validation efforts including sterilization process that include but are not limited to: Sterility testing Endotoxin testing Bioburden product monitoring Aid Microbiology manager where appropriate in completing assigned tasks and deliverables on time, as they relate to project product sterilization validations, revalidations, and product development Ensure proper microbiology laboratory test practices and media/reagent qualification and storage Interprets and evaluates test analyses in terms of accuracy and precision compared against established specifications and recommends corrective actions when necessary Support recommendations and aid in implementing laboratory efficiency modifications Perform tasks necessary to support execution and documentation of routine dosimetric audits for gamma-sterilized products Perform environmental monitoring, trending and reporting Ensure proper personnel hygiene standards in the microbiology laboratory and production areas Conduct or contract microbial identification Maintain analytical test methods and procedures Investigate and help Value Stream resolve microbiology issues (NCR's, NC's, CAPA) Maintain Microbiology data and databases, file approved test reports in a timely manner Promptly complete routine tasks such as Basware coding, LearnIt training and Veeva Vault reviews/approvals. Perform microbial plate counting Maintain manual temperature, RH and pressure logs Shipping of samples to contract lab LAL biochemical verifications Daily sample log-ins Other duties as assigned Basic Qualifications BS/BA in Microbiology, Biology or related Science 3-8 years relevant experience, preferably in a medical device manufacturing environment Strong laboratory background Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies. Required Knowledge, Skills and Abilities Knowledge of microbiology laboratory equipment and techniques Strong verbal and written communication skills for multi-level company interaction Strong knowledge of Microsoft Office and document database workflow Well organized and detail oriented Effective ability to analyze problems, work independently, and organize and execute multiple work tasks Effective ability to coordinate work with contract laboratories/facilities Knowledge of GMP, FDA QSR, ISO, AAMI/USP regulations/standards/monographs Experience in EtO gas, gamma radiation, and other sterilization validation methods and requirements per ISO 11135 and ISO 11137. Experience conducting bioburden, LAL endotoxin / pyrogen testing and device sterility testing Environmental, Health and Safety Responsibilities This position will support Coloplast Manufacturing EHS Goals and Objectives: Comply with company standards for environment, health, and safety. Work in a safe and efficient manner. Provide detailed instructions for job performance and explain hazards and safety precautions in assigning employees to a task or writing instructions. Plan the work to be certain that employees, material and equipment are available to perform task safely. Take precautions to prevent unnecessary impacts on environment, health and safety when developing products, technologies, and business areas. Immediately report unsafe conditions or job hazards. Report accidents, injuries, illnesses, near misses and property damage to your Supervisor. Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the worlds leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things. Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because - and not despite - of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability. Visit us on . Watch the film. Follow us on LinkedIn. Like us on Facebook. 57074 #LI-CO Nearest Major Market: Minneapolis Apply now Find similar jobs: EOE M/W/Vets/Disabled
Created: 2024-09-23