About Nucleus Biologics
At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations.
Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability.
About the role
The Quality Engineer will be responsible for supporting multiple QMS functions. The ideal candidate will have a strong background in compliance (nonconformance, CAPA, complaints, audit support), document control, product release and operational excellence with a commitment to maintaining high standards of quality and accuracy. Additional background with regulatory compliance, stability protocols and environmental monitoring are preferable.
What you'll do:
Compliance
- Assist in the management of the Complaint, Nonconformance and CAPA process.
- Collaborate with cross-functional teams to investigate quality issues, identify root causes, and develop appropriate corrective and preventive actions.
- Analyze data and trends to identify opportunities for systemic escalations, process improvement and quality enhancement
- Provide support for all external and internal audit programs.
Document Control
- Provide ongoing support of the document control system. This includes overseeing the creation, review, approval, distribution, and archival of quality documents such as work instructions, batch records, and quality records.
- Ensure compliance with regulatory standards (e.g., FDA, ISO) and company policies related to document control processes and documentation management.
- Issue necessary documentation and/or labeling to support upcoming production need
Product Release
- Review batch records, manufacturing documentation, and associated data to ensure accuracy, completeness, and compliance with established procedures and regulatory requirements.
- Support the execution and/or review of Quality Control related activities necessary for raw material and finished good releases.
Operation Excellence
- Assist with conducting analyses of existing business processes to identify inefficiencies, bottlenecks, and areas for improvement.
- Collaborate with cross-functional teams to develop and implement process improvement initiatives aimed at enhancing operational efficiency and effectiveness.
- Partner with senior leadership to align operational excellence initiatives with strategic business objectives and priorities with results being demonstrated through the development of key performance indicators (KPIs).
Qualifications:
Requirements
- Bachelor's degree in engineering, life sciences, or a related field preferred. A combination of education and experience will be considered for this position.
- 3-5 years’ direct experience in a cGMP biotech or pharmaceutical environment as they relate to the responsibilities outlined in this job description.
- Strong knowledge of GMP, ISO, and regulatory requirements.
- Experience with the development and/or execution of stability programs and environmental monitoring preferred.
- Experience with quality management systems (QMS) and electronic documentation platforms.
- Excellent problem-solving, analytical, and organizational skills.
- Strong communication and leadership abilities, with experience managing cross-functional teams.
- Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships.
- Strong attention to detail
- Ability to exercise independent judgment consistent with Company guidelines
Additional Skills
- Ability to independently develop and manage projects and timelines
- Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships
- Strong attention to detail and process mindset
- Ability to exercise independent judgment consistent with Company guidelines
- Excellent verbal and written communication skills.
- Familiar with statistical process control methods.
Physical Requirements
- Ability to hear and speak to employees and external associates on the phone and in person.
- Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
- Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions
Travel Requirements
- May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position.
NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.
