Microbiologist
AtriCure
- Cincinnati, OH
- Permanent
- Full-time
- Execute routine microbiological testing sampled from a classified controlled environment, including enumeration, gram stain and organism ID to support the EM program.
- Execute routine microbiological testing sampled from various utilities systems to support the EM program.
- Execute component and product testing of medical devices through execution of membrane filtration and plate count methods, endotoxin analysis, growth promotion and microbial identification.
- Support implementation of new instruments, equipment and methodologies as required including performing/ reviewing IQ/OQ/ PQ data for qualification.
- Perform data entry, laboratory reporting and record keeping following good documentation practices as required.
- Control handling of samples and data integrity to ensure chain of custody for all testing performed.
- General laboratory housekeeping duties, sample receipt, expiration and inventory checks as well as maintenance of the lab and equipment.
- Coordinate the compilation and reporting of results through monthly metrics, trend reports and dashboards.
- Analyze data and metrics and notify appropriate personnel of negative trends, alert and action level excursions.
- Generate non-conformance reports as necessary and support out of specification investigations.
- Suggest and implement procedure and process changes to align with current industry standards and practices.
- Support team with quality system tasks including investigations, CAPAs, etc.
- Regular and predictable work performance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgement
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Ability to work safely, seek out and encourage safe practices.
- Ability to learn on the job and ask effective questions.
- Critical thinker, ability to identify issues and work quickly to bring to resolution.
- Ability to suggest and support implementation of lab improvements or modify existing process to maximize quality and efficiencies in the lab.
- Ability to stay organized and use effective time management skills, multi-tasking and priority setting skills with attention to detail, quality, and accuracy.
- Ability to give and receive feedback appropriately and implement feedback effectively.
- Effective oral and written communication skills with peers and management.
- Commitment to teamwork and continuous improvement.
- Self-started, motivated, scientifically curious and collaborative.
- Ability to maintain a positive outlook and remain flexible in a complex, changing environment and be able to deliver results on time.
- Adheres to performance goals and holds self-accountable for work performance.
- On-site schedule
- May be required to participate in various shifts, holiday or weekend work as needed.
- Additional duties as assigned
- Bachelor’s degree in discipline such as Microbiology, Biology or demonstrated equivalent combination of education, training, with 3+ years of experience in a GMP laboratory.
- Experience and understanding of aseptic technique.
- Experience with lab methodologies and equipment.
- Experience with Microsoft Word, Excel and PowerPoint
- Travel up to 10%
- Experience in medical device, pharmaceutical microbiological testing, or related micro laboratory testing in a regulated environment.
- Knowledge of ISO 13485, ISO 11737-1, ISO 11737-2, ISO 17025, AAMI ST72, USP
, USP
161
, USP
61
- Experience and understanding of cGMPs and applicable regulations and standards related to controlled manufacturing environments and Good Laboratory Practice.
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to regularly lift 25 pounds, occasionally lift up to 50 pounds
- Ability to pass pre-employment drug screen and background check