Manufacturing Associate Technician Production Operations I (O1)

Job Summary (List Format):

- Formulate fill test and package chemical and biological reagent products according to operational plans and customer demand.
- Follow established work instructions SOPs engineering drawings and FDA requirements to ensure product quality and compliance.
- Execute daily production plans ensuring due date conformance and adherence to quality standards.
- Independently perform tasks related to formulation filling testing and packaging of products.
- Set up calibrate test and troubleshoot reagent components and instruments.
- Conduct solution testing (pH conductivity density) to verify adherence to specifications.
- Maintain accurate production records and complete necessary paperwork.
- Comply with FDA Quality System Regulations (QSR) Good Manufacturing Practices (GMP) and ISO requirements.
- Collaborate with cross-functional team members to resolve issues and maintain a quality focus.
- Identify and suggest process improvements for product quality methods and equipment efficiency.
- Participate in lean manufacturing and continuous improvement initiatives.
- Maintain a safe clean and organized work environment by following procedures and safety rules.
- Train new team members on equipment operation and work procedures as needed.
- Utilize Microsoft applications for daily tasks and reporting.
- Meet physical requirements including standing for prolonged periods lifting up to 30 lbs and performing repetitive hand movements.
- Must have at least 2 years of relevant experience preferably in a regulated industry (FDA ISO).
- Strong communication skills in English both spoken and written.
- Demonstrate solid decision-making priority-setting and teamwork skills in a diverse environment.