Operations Associate I (OA I)
Operations Associate I, Technical Systems
Department / Cost Center:
BioAnalytical Sciences/ 223
Reports to (Job Title):
BAO Manager or Sr Manager
State the overall function or purpose of the job.
The Operations Associate I, Technical Systems (OA I) function is to support activities in the BioAnalytical Sciences R&D and GLP compliant laboratories encompassing the areas of laboratory equipment calibration and maintenance, laboratory facility maintenance, Records Coordination and reagent preparation. The OA I is responsible for routine maintenance and calibration of analytical instrumentation, reading of temperatures on controlled temperature environment (CTE) chambers, general laboratory facility maintenance for safety and compliance, good documentation practices, records coordination activities, glasswashing and mixing of common reagents. The OA I functions to maintain regulatory compliance and good business practices.
List the major responsibilities of the job.
- Performs routine instrument/equipment maintenance and calibration checks to ensure the proper function and compliant use.
- Performs good documentation practices with instrument and equipment laboratory logbooks and ensures compliance in their documentation.
- Performs routine laboratory facilities checks to ensure proper maintenance and compliant use of the laboratory areas.
- Assists the project manager in equipment implementations and upgrades into the laboratory.
- Ensures GLP-compliant laboratory operations.
- Participates in internal and external inspections and audits.
- Completes regular training on procedures and GLPs for compliance.
- Performs archivist duties in the role as a Staff BAS Archivist for documents and specimens.
- Coordinates and performs common reagent preparation of wash buffers and other necessary routine reagents used in research and validated, GLP assays.
- Participate and contribute ideas in process improvement meetings
- Participates in projects or tasks assigned
- Maintains inspection readiness
Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
The OA I is integral to the general laboratory workflow. Maintaining and calibrating laboratory equipment and instrumentation for compliant GLP testing and R&D use. Preparing reagents for use in compliant GLP testing and R&D laboratories. The OA I maintains readiness and has a significant impact on the Bioanalytical Sciences department’s goals of meeting deadlines and maintaining high quality standards of testing required in a GLP regulated environment.
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
- Minimum: Completion of high school diploma or equivalent and work experience in a scientific laboratory.
- Preferred: Associates degree in a scientific discipline and experience as a laboratory technician, laboratory assistant, sample processor, or phlebotomist in a bioanalytical or medical laboratory.
- Preferred: Bachelor’s degree in biology or biochemistry discipline and a background in specimen processing, phlebotomy, medical technology, and/or clinical laboratory science.
State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
- Minimum: 2 years relevant work experience.
- Preferred: Associates degree with 1 year experience with specimen processing in a clinical or non-clinical laboratory.
- Preferred: Experience with GLP or GMP documentation.
- Preferred: Bachelors degree with 1 year experience in a bioanalytical or medical setting.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; biohazardous materials; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Describe any equipment required to perform the job.
- Thermometers/Temperature monitors
- Computer System
- Controlled Temperature Environments (CTE)
- Ultra Low Temperature (-80 degree C) Freezers
- Electrochemiluminece Analyzers (ECLA)
- Document filing cabinets; fireproof and regular
List the key positions, internal and external, with which the job incumbent must interact.
- Manager, Associates, BioMarin GLP Compliance.
- Clinical Research Associates, BioMarin Clinical Operations.
- Associates, Scientists, Director, BAS
- Associates, Scientists, Director, CoTe
- VP, Directors, Scientists, Associates, Pharmacological Sciences
- Facilities personnel
- Personnel at clinical sites, collaborators, vendors and contract research organizations.
List the number of personnel directly reporting to this position and their job titles. List the number of personnel functionally reporting to this position (i.e., supervised on a “dotted-line” basis), and their job titles. Specify the total number of personnel supervised by this position, both directly and through others.
This position does not have any reports.
List the key accomplishments and skills that must be achieved to be eligible for promotion to the next position, if any, on the career ladder.
Operations Associate II (OA II) would have to demonstrate proficiency in required skills in present position, show initiative, and demonstrate clear communication and organization. Must also show capability to train new personnel and development of technical writing skills.