QC (Quality Control) Lead

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

This individual will be part of the site’s Quality/Analytical team working closely with production to maintain operational QC processes and support site continuous improvement and expansion projects.

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:

· Hands on testing support of in process production samples and final product release testing

· Oversee daily Quality Control processes to support production needs and Quality Management Process compliance

o Monitor daily testing needs and support as necessary

o Oversee method QC statistics and reports

o Perform QC Release of intermediates and final products as per requirements

o Monitor, oversee and perform general laboratory duties including equipment maintenance, preparation of reagents, inventory monitoring, and ordering/receiving of lab supplies (as needed)

o Supervision of other Quality/Analytical team members

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

o Key internal auditing resource

o General laboratory Quality Control oversite

o Corrective and Preventative action programs

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

· Work collaboratively in cross functional 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, microbiology, biotechnology, etc.) and/or equivalent experience, preferably at a biochemical/biotechnology/food processing company with 5-10 years of work experience including representative laboratory experience (HPLC, wet chemistry, gel electrophoresis, enzymology)

· Experience with Quality Control processes including process control tracking and method troubleshooting

· Experience in an ISO 9001:2015 and/or ISO 17025 certified environment

· Proficiency with LIMS systems and QMS software programs (Document Control, Training, CAPA, Nonconformance Management)

· 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:

· Food or cGMP Quality Control background

· ISO 9001:2015 Internal Auditor Certification

· Previous QC laboratory supervisory experience

· Experience with enzymatic kinetics, PCR, and HPLC methodologies