Operations Technical Specialist

Description

Job Title: Operations Technical Specialist 1                                                                         

Job Summary

• The Operations Technical Specialist 1 supports various areas of manufacturing including production and testing by, under guidance, executing tasks for resolution of technical challenges, business continuity or continuous improvement initiatives related to product or processes.   

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 

• Primary responsibility for this position is supporting scientific staff with experiments or other activities for resolution of challenges related to release of product such as nonconformance investigations.  
• Under guidance, execute protocols as well as generate data summaries using data analysis tools.
• Occasionally may be responsible for performing testing for GMP release of product. 
• Operates laboratory equipment to generate timely, reliable, and accurate data. 
• Performs activities essential to laboratory daily operations (e.g., equipment maintenance, executing cleaning requirements, upkeep of supplies, etc.). 
• Maintains a working knowledge of Client assays, technology, and instrumentation. 
• Performs tasks to support efforts related to resolution of quality records, technical challenges, business continuity or continuous improvement efforts. 

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting/moving and carrying products weighing up to 40 pounds.
• Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• Exposure to hazardous chemicals or other materials.
• Safety Shoes with Impact and Compression Protection Must be worn.
• Exposure to blood.

Qualifications

Education       

• BA or BS degree and 1-3 years related experience in scientific discipline.

Experience     

• Knowledge of cGMP, QSR and ISO regulated environments including knowledge of compliance enforcement necessary for 510K and PMA products.

Skills

• Conducts tasks in accordance with Good Laboratory Practices (GLP). 
• Ability to operate and perform limited trouble shooting of complex lab equipment. 
• Demonstrates strong peer to peer communication skills as well as possessing the ability to effectively communicate inter-departmentally. 
• Ability to analytically interpret data of minor complexity and present to peers. 
• Ability to triage tasks with competing priority and recognize sense of urgency.   
• Willingness and ability to adhere to FDA cGMP, ISO13485, company and department procedures.
• Ability to work well under supervision and take direction on increasingly complex projects.
• Working knowledge of scientific writing techniques.
• Affinity for a workload focused on laboratory centered tasks. 
• Ability to execute tasks in line with productivity expectations.