Senior Research Associate - Microbiology/Validation

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range:

$62,300.00 - $102,350.00

POSITION SUMMARY

The primary responsibilities as a Senior Research Associate in the QC Microbiology team include leading method validations (USP<71>, bioburden) for new products, leading equipment validations, and providing support for environmental monitoring and water testing (DI, WFI) at both the Minneapolis and St. Paul sites. As the validation lead for the team, the successful candidate will bring experience with method validations and equipment IQOQPQ. Support for environmental monitoring and water testing involves carrying out testing and distributing results, data entry & analysis, presenting data to stakeholders, and leading investigations for non-conformance events in the case of OOS results. Experience with data analysis (e.g., JMP, R) would be an asset in this role.

Additional responsibilities of the Senior RA position include USP <71> & bioburden testing of products, general lab duties including stocking, purchasing, receiving, cleaning, and other duties as assigned. This position will also be responsible for developing, writing, and performing new procedures. The successful candidate will have excellent attention to detail, strong organizational and multitasking skills, and the ability to work collaboratively with other departments.

The Senior Research Associate will be responsible for training and mentoring junior staff members to ensure the highest level of quality and accuracy in all testing procedures.

This role will involve driving between the St. Paul and Minneapolis Bio-Techne sites.

ESSENTIAL FUNCTIONS

1. Coordinate and lead validations for equipment and bioburden/sterility testing methods in compliance with cGMP, USP, and ISO regulations.

2. Perform and review testing and reporting for the environmental monitoring programs, including air, surface, particles, and DI/WFI bioburden. This includes sample collection, set-up, and reading, as well as follow-up and troubleshooting of results and issuing corrective action forms. Present data to stakeholders.

3. Assist and review bioburden and sterility QC testing of raw materials, bulk products, and finished products using various culture methods including direct plate, broth dilution, and membrane filtration. This includes culture set up, reading, and recording, as well as reporting via hard copy distribution and electronic and scanning.

4. Coordinate and lead with efficacy / validation testing.

5. Miscellaneous administrative duties including: printing documents and making copies; revising / reviewing SOP documents; raw materials check-in.

6. General lab duties including: cleaning and maintenance of cleaning logs; biohazard disposal; temperature recording; formulation and filtering of in-house media/rinse solutions.

7. Assist with the monitoring of lab supplies and ordering.

8. Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job.

9. Performs additional duties as assigned.

JOB SPECIFICATIONS

Education and Experience:

Position requires a B.S. degree in Microbiology or a related field or equivalent, with a minimum of 4-8 years microbiology lab experience, Master’s Degree with 2-4 years experience. Attention to detail, organization, data analysis and problem-solving skills are required. Working knowledge of Microsoft Word and Excel are required. Computer entry and/or typing skills are desirable. Must be able to work in a fast-paced environment, multitask, and have good communication skills, both verbally and in writing.

Knowledge, Skills, and Abilities:

1. Knowledge of basic computers and Microsoft Word and Excel.

2. Knowledge and skills pertaining to laboratory equipment.

3. Knowledge of microbiology culture procedures. Ability to learn and consistently execute laboratory tasks, using excellent aseptic technique.

4. Skills in problem solving; including the ability to identify and appropriately evaluate a course of action.

5. Ability to act independently on routine assignments or projects.

6. Ability to plan, organize and multi-task to complete assignments in an efficient manner.

7. Skill in establishing effective inter- and intra-department relationships and be able to determine the appropriate actions to be taken with incoming samples and assist submitting personnel in a professional manner.

8. Ability to com