Microbiologist

AtriCure•Mason, OH

20d•Onsite

About The Position

POSITION SUMMARY: This position will be responsible for executing microbiological testing in a GMP regulated environment to support environmental monitoring and product testing requirements. Additionally, the role may support non-routine projects, validations, and method developments to meet departmental and individual goals. ESSENTIAL FUNCTIONS OF THE POSITION: 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. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: 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 scheduleMay be required to participate in various shifts, holiday or weekend work as needed. Additional duties as assigned

Requirements

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%
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

Nice To Haves

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 <85>, USP<161>, USP <61>
Experience and understanding of cGMPs and applicable regulations and standards related to controlled manufacturing environments and Good Laboratory Practice.

Responsibilities

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.
May be required to participate in various shifts, holiday or weekend work as needed.
Additional duties as assigned