iuvo BioScience is a Premier Partner Research Organization serving the Medical Device, Pharmaceutical, and Ophthalmic industries. We provide strategic guidance and testing services – from research to release - leveraging our preclinical testing, CMC/technical services, and clinical research experience to deliver exquisite science, develop valuable insights, and author flawless documentation. We do it all with a commitment to exceptional service.

We offer a comprehensive benefits package (medical/dental/vision/401k/PTO) and the opportunity to broaden your experience working with top level medical device and pharmaceutical clients to improve the quality of life for patients and consumers around the world.

We currently have an opening for a TECHNICIAN to join our Microbiology team.

SUMMARY

The Technician performs routine and complex Micro laboratory testing for our pharmaceutical, medical device, compounding pharmacies and other customers. Testing includes sterility testing, sterilization process validation support, biorburden, AET, EM, water systems testing, medical device microbial ingress testing, as well as more complex studies such as disinfectant efficacy, recovery studies, reusable device cleaning studies, instrument qualification and calibrations. All work is performed after proper training and always following iuvo BioScience SOPs and cGMPs as applicable.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The responsibilities with respect to performing tests and/or calibrations:

• Conduct routine testing independently and supports complex studies.
• Assist with equipment qualifications, re-qualifications and associated activities
• Perform advanced laboratory techniques with scientist supervision.
• Perform activities in compliance with all applicable SOPs & regulations – ISO, cGMP, HSE
• Assist with preparation of work instructions for review and approval
• Participate in training as defined by management.

The responsibilities with respect to the planning of tests and evaluation of results:

• Perform work on-time according to schedules
• Assist with execution of GMP protocols and reports, including data collection in accordance with Good Documentation Practices.

The responsibilities for interpretation and reporting of data:

• Perform data review and reporting of standard test methods.
• Perform review of laboratory documentation.
• Provide data trending and analysis of standard testing.
• Communicate any potential out of specification conditions or deviations to department leadership per SOPs and cGMP expectations for MDDI management.

The responsibilities with respect to method development, modification and validation:

• Assist with method development, modifications and validation.
• Participate in proficiency testing for standard methods

Supervisory duties: None

QUALIFICATIONS & REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION and/or EXPERIENCE

Associates degree (BS preferred) in a related scientific field, preferably biology/microbiology, with 3-5 years of experience in a cGMP testing environment – or the equivalent combination of education and experience.

COMPUTER SKILLS

Proficiency with Microsoft Office (Word, Excel, Outlook).

COMMUNICATION SKILLS

Must be able to effectively communicate verbally and in writing with management, co‑workers and clients. Read and comprehend work instructions/SOPs and protocols and write clear concise reports.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and manipulate equations involving exponential and logarithmic functions. Must be able to use metric.

OTHER SKILLS and ABILITIES

Ability to analyze, interpret and draw conclusions from data and exhibit problem solving and trouble shooting skills.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear.

The employee must frequently lift and/or move up to 30 pounds and occasionally lift and\or move up to 50 pounds. Specific vision abilities required by this job include close, color, and peripheral vision and the ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Combination of office and laboratory settings (with typical laboratory risks) where moderate noise levels may exist.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LOCATION Rush, New York

TRAVEL None

DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

iuvo BioScience is an Equal Opportunity Employer