Operations Technical Associate I

Job Title: Operations Technical Associate I
Job Location: San Diego, CA 92121
Job Duration: 6+ Months (Possibility of extension)


Pay Range: $26 - $30 /hr. on w2
 
INTAKE NOTES:

• Must be onsite.
• Extension: Possible.
• Hours: Flexible, but should roughly coincide with 8:00 AM – 5:00 PM.

 
Skillset Matrix Manager Notes:

• Technology Requirements (Programs, Systems, etc): Working knowledge of Excel.
• Typical Day (Daily Tasks): Review test requests, pick up samples/reagents for testing, prepare lab equipment for testing, prepare samples/reagents for testing, execute testing, analyze data as needed.
• Preferred Background/Prior Work Experience: 1 – 3 years of experience in a lab-based role using general laboratory techniques (preparing dilutions, etc.).
• Priority Soft Skills: Strong peer-to-peer communication.

 
Position:
Operations Technical Specialist 1
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.
• Operate laboratory equipment to generate timely, reliable, and accurate data.
• Perform activities essential to laboratory daily operations (e.g., equipment maintenance, executing cleaning requirements, upkeep of supplies, etc.).
• Maintain a working knowledge of *** assays, technology, and instrumentation.
• Perform 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.
• Other (please specify): —

 
Qualifications:
Education:

• BA or BS degree and 1–3 years of related experience in a scientific discipline.

Experience:

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

Skills:

• Conduct tasks in accordance with Good Laboratory Practices (GLP).
• Ability to operate and perform limited troubleshooting of complex lab equipment.
• Demonstrates strong peer-to-peer communication skills and 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 priorities and recognize a 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.