QC Lead- Supervisor

QC (Quality Control) Lead – Supervisor

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
  • Monitor daily testing needs and support as necessary
  • Oversee method QC statistics and reports
  • Perform QC Release of intermediates and final products as per requirements
  • Monitor, oversee and perform general laboratory duties including equipment maintenance, preparation of reagents, inventory monitoring, and ordering/receiving of lab supplies (as needed)
  • Supervision of other Quality/Analytical team members
• Support Quality Control processes associated with ISO 9001:2015 certification
  • Key internal auditing resource
  • General laboratory Quality Control oversite
  • 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:

• 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