Quality Specialist I

We are expanding our Rochester Manufacturing team and are seeking an exceptional, highly motivated Quality Specialist to play a key role in production, optimization, and characterization of our RNA-based products.

This individual will be part of the site’s Quality/Analytical team working closely with the production performing a wide range analytical and microbiological analysis.

Excellent technical, organizational, and communication skills, along with a commitment to excellence and high-quality work are required.

Level is dependent on qualifications including relevant work experience

Responsibilities:

· Prepare & execute daily laboratory testing to support the production of commercial products and precommercial materials.

o Including HPLC methodologies, gel electrophoresis, RT-PCR, wet chemistry methods and microbiological plating/ID

· Accountable for the precision and accuracy of data analysis and timely processing of samples and data reporting

· Perform general laboratory duties including equipment maintenance, preparation of reagents, inventory monitoring, and ordering/receiving of lab supplies

· Support Quality Control and Quality Assurance processes associated with ISO 9001:2015 certification and cGMP processes

· Work collaboratively in cross function teams to accomplish project goals and milestones

· Contribute to operational excellence improvement projects to continue to improve the quality management systems of the growing organization

Qualifications:

· B.S. in technical field (i.e., chemistry, biochemistry, biotechnology, etc.) and/or equivalent experience, preferably at a biochemical/biotechnology/pharmaceutical/food processing company with 1-3 years of work experience

· Experience with general wet chemistry analysis

· Great attention to detail, organization and time management, problem solving abilities and a willingness to help wherever needed

· Proficiency in using MS Excel, PowerPoint and WORD is required.

Pluses:

· Experience with HPLC/UPLC including Agilent Chemstation, Waters Empower, or similar chromatography data systems.

· Experience with gel electrophoresis and RT-PCR techniques

· Experience in an ISO 9001:2015, GLP and/or ISO 17025 certified facility or laboratory

· Experience in Food or cGMP Quality Control

· Proficiency with LIMS systems and QMS software programs