Job Description
A Production Chemist position is available at nanoComposix. This is a highly collaborative and hands on opportunity. Responsibilities include working with the team to ensure that the lateral flow production schedule is maintained, all quality control measures are in place and followed, all reagents and cards are manufactured, processed and characterized as specified under a formal quality system, all team members are trained and have all of the tools necessary for success. See full list of responsibilities below.
For more information, please visit our career page at nanoComposix.com/pages/careers.
RESPONSIBILITIES/DUTIES:
- Execute lab activities including bioconjugation to surfaces or particles.
- Supervise and assist with production on BioDot reel to reel dispense system.
- Meticulously document production into batch records and forms associated with NCX quality system.
- Collaborate with lateral flow development team to transfer multiple assays to manufacturing.
- Participates in Lean Initiatives and Activities.
- Assist in nonconforming and customer complaint investigation.
- Ensuring that the manufacturing area is compliant with all required FDA, ISO and other applicable regulatory agency standards and documentation.
- Ensuring that the manufacturing area is compliant with the requirements associated with EHS, HR, Facilities, Housekeeping, etc.
- Maintains appropriate inventory levels of raw materials and supply items used in manufacturing.
- Develop and initiate policies and/or procedures for continual metric improvement.
- Assist when needed in both external and internal inventory audits.
- Review manufacturing records for accuracy and completeness in accordance with GMP.
- Coordinate lab shutdown activities to prevent production disruption.
- Actively contribute to team discussion, project planning and project execution.
- Maintain an organized, safe and efficient work area at all times.
- Resolve routine issues and escalate non-standard or critical issues.
- Support new product transfer and validation and implementation of process improvements.
- Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per ISO, FDA and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.