Position Title: Operations Technical Associate I

Work Location: 10210 Genetic Center Drive, San Diego, CA, 92121, USA

Assignment Duration: 6 Months

Work Schedule: Hours are flexible but should roughly coincide with 8AM – 5PM

Work Arrangement: Must be onsite

Position 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.

Key Responsibilities:
• 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 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:
• 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.
• 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.

Qualification & Experience:
• BA or BS degree and 1–3 years related experience in scientific discipline.
• 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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 26.00/hr.