Reports to: Manager, Reagent Manufacturing

Summary

• Manufacturing Specialists are required to have a strong knowledge of manufacturing methods and techniques, process development experience, work flow understanding, ability to understand formulations and follow recipes and testing protocols for any in-process Quality checks
• In this position, Manufacturing Specialists, will maintain manufacturing equipment, create work instructions, train others, often be asked to contribute to or lead projects, be cross functionally trained to work in several areas as needed.
• This role requires a self-starter, ability to work independently, understanding of departmental goals-working as a team to achieve those goals within set timelines.

Role and Responsibilities

• Perform Reagent Assembly in accordance with Manufacturing Procedures (MPs), drawings and related Work Instructions (WKI).
• Prepare testing samples per Quality Testing (QT) procedures and instructions
• Carry out work in accordance with defined Quality Management System procedures, and support Quality initiatives.
• Support general Manufacturing objectives.
• Support systems development pilot production and experimental work orders, as required
• Assist in maintaining fixtures, assembly tools, assembly instrumentation and manufacturing job aids.
• Be committed to following and supporting safety practices.
• Prepares for production by reviewing work orders and production schedule, studying and clarifying specifications; calculating reagents and chemicals, as well as part requirements; collect materials and supplies. Set-up equipment necessary for different work orders.
• Documents production by completing applicable forms, reports, logs, and records equipment and batches using GDP practices.
• Keeps work areas clean and organized
• Contributes to Continuous Improvement efforts; Identify and help implement process, procedure, safety improvements.
• Complete and maintain training records within expected timelines.
• Maintain functional understanding of cGMP’s and the impact of deviation from controlled processes and/or procedures. Participate in investigations as needed.
• Train/mentor less experienced and new operators.
• Maintain inventory; be familiar with Kan Ban, and FIFO. May be required to complete inventory counts periodically.
• Completes other tasks as assigned.

Qualifications/Experience

• College Degree (BS/BA) in science or chemistry field plus 1 year relevant Lab or Reagent production work experience or an Associate’s degree and 2 years relevant work experience.