Sr. Production Associate

Position Objective: Work in a team based environment to manufacture research, clinical and commercial products that are scientific in nature for use in the life sciences industry. Implement production and large scale manufacturing procedures to optimize processes and meet regulatory requirements. Actively participate and contribute to New Product Development and Introduction, process improvement and team management. Core Essential Functions:• Perform and improve manufacturing processes in conjunction with Team Scientists. Understand the written production documents and be technically capable of performing and improving processes and procedures to maintain inventory of those products. Possess scientific understanding of team products and their applications. Carry out scientific operating procedures involving complex laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products, requiring scientific understanding of what they are working on. Responsible for Batch Data Records, notebooks, customer reports and work order documents. • Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating parameters. Advise manager of factors that may affect quality, accuracy and usefulness of product. Suggest options / ideas for corrective actions. • Produce and conduct quality analysis of and improve reagents, components, and finished products in accordance with the manufacturing plan.• Complete production and quality analysis of reagents, components and finished products in accordance with the Production Schedule.• Maintain accurate inventory of raw materials, WIP and finished product. Capable of using advanced ERP functions.• Maintain equipment, product inventories and related records as assigned. Note variances on manufacturing documents; audit and evaluate process documents and propose revisions.• Actively participate in NPI/product and process development activities. Codevelopment with R&D throughout NPI process as required. Actively participate in the identification of and implement manufacturing procedures intended to optimize existing processes and ensure achievement of regulatory requirements. Procedures will typically target improvements in product yield and reduced manufacturing time and cost. • Actively participate in troubleshooting and variable identification for specific processes or activities as assigned. Report findings to team management and members with recommendations for improvement. • Analyze and interpret scientific data. Utilize specialized technical knowledge or skills necessary.• Communicate effectively with every member of the team as well as with the team leader, manufacturing management and planning/purchasing team members. Works across functions. Maintain communication with representatives from other departments and teams as required, including coordinating with other teams internal and external to operations to share resources. Respond to the teams or customers technical inquiries in a professional and timely manner. In addition, works across various functions as required.• Actively participate in Team activities (conflict resolution, team building, scheduling).• Recognize manufacturing problems, identify variables, perform appropriate experiments, and make necessary corrections to manufacturing processes.• Keep a clear, complete and accurate account of all manufacturing and product development work through the appropriate use of Batch Data Records, notebooks, customer reports, work order documents, etc.• Critically evaluate, revise and/or create process documents. Ensure that efficient, reproducible, quality manufacturing processes and documents are developed for new and existing products. • Train and coach team members in more advanced technical manufacturing skills, trouble-shooting, process Improvements and understanding, safe laboratory practices and hazardous materials handling and disposal. Offer technical guidance and direction to team members.• Provide technical product support and accurate product availability information in a timely manner. • May research new methods or steps in a process and present findings and recommendations to the team, including developing new and revised Standard Operating Procedures.• Demonstrate good work ethic by following Manufacturing Core Values: F.O.R.C.E. (Fun, Ownership, Respect, Continuous Improvement and Empowerment).• Ensure adherence to quality standards established in process documents. Continually strive to improve product quality through establishment of more effective or efficient manufacturing processes and quality testing. Effectively communicate the importance of total quality to the members of the team.• May perform other related duties as required and/or assigned.Non-Core Functions:(Process) Take an active role in scientific training of team members. Train and coach team members in the science and application of processes and products manufactured by the team. (Process) Seek additional training or education for career development (i.e.: attend journal clubs, meetings and seminars).(Process) Submit data or articles for publication as required.(Process) Lead team problem solving by demonstrating and training team members in experimental design.(Process) Initiate and implement appropriate experiments to address failure of product or processes to yield expected results. (Process) Offer validated alternative production processes and or schedules in order to improve manufacturing efficiency.(Operations) Provide leadership and direction to the manufacturing team, in support of manufacturing the highest quality product possible. Work with the team members and planning/purchasing teams to develop and execute a manufacturing schedule consistent with master schedule requirements for team products. Coordinate team resources to ensure the most efficient use of time and materials.(Operations) Create training plans for employee development.(Operations) Ensure team members comply with company attendance policies. Participate with the team leader in performance evaluations of team members.(NPI) Participate in all activities regarding New Product Introduction. Involved in all processes to ensure full understanding of introducing new products to team. Partner with Team Leader to ensure full training.(Process, NPI) Evaluate and propose quality standards for production procedures and products (i.e.: coordinate vendor qualification of new products and parts).(Process, NPI) Keep team members informed on all new product information, appropriate scientific data, problems, concerns and updates with regard to manufacturing processes.(Process, NPI) Present journal articles or similar material at department or company meetings, at least twice per year.(Process, NPI) Identify and interpret the scientific basis of each manufacturing process in use by the team. (Operations, Process, NPI) Coordinate team, inter-team, or inter-departmental problem solving teams as required.(Operations, Process, NPI) Works with Environmental Health & Safety to assure guidelines are followed.Education:Requires a Bachelors degree in a scientific or technical field or the equivalent knowledge and experience. Experience: Requires at least five (5) years experience in the application of laboratory techniques in a manufacturing environment or research laboratory. Demonstrated proficiency in the use of basic laboratory techniques, equipment and materials required. Demonstrated ability to follow standard protocols required. Experience assessing current processes and techniques and implementing procedural improvements preferred. Good problem solving skills necessary. Working knowledge of manufacturing related computer software preferred.