1. Job Summary
This position requires knowledge that is acquired through experience, specialized education or training. The role has clearly defined procedures and tasks as well as defined guidelines to aid in decision making. The job requires a basic understanding of work routines and procedures in own discipline. The technical procedures for this level are well defined. The job works within well-defined procedures that may involve a variety of work routines. This job typically requires a minimum of 2 or more years of experience.
The Lab Technician I is responsible for execution and recording of results for all laboratory testing. This position will support all sterility assurance, product quality, & endpoint testing for operational support and release. In addition, the Lab Technician I will support all activities to sustain required testing and monitoring, this to include sample collection, shipping, testing submittal forms, and purchase order generation. The Lab Technician I will assist and maintain department equipment and consumables related to environmental monitoring, product testing, and sterility assurance activities.
Assists in developing and validating testing methodology used to control raw materials, production intermediates and final products. Helps establish, validate and document new or existing compound identification methods. May conduct testing of analytical samples for the laboratory area, the separation and characterization of protein drug candidates, formulation development, peptide mapping and other analytical methods of development. Conducts work in compliance with cGMP, safety and regulatory requirements. May provide analysis and evaluation of material and products at all stages of development process.
2. Responsibilities and Functions
Execute and record results of all laboratory testing conducted, which includes, but not limited to viable and non-viable air monitoring, microbial surface testing, media testing, endopoint testing and water testing.
Execute laboratory assays as trained and directed to support product quality monitoring.
Ability to perform basic aseptic transfer technique in microbiological assays.
Ability to operate basic lab and test equipment.
Responsible for accurate and organized maintenance of quality records according to the established procedures.
Communicate effectively within the organization to ensure proper action is taken to resolve corrections needed.
Coordinates and assists in equipment preventative maintenance, calibrations, and qualification activities.
Assist with sterilization validation execution, including product sample coordination and dunnage builds.
Maintains accurate records.
Ability to communicate findings effectively in oral and written form with the aim of improving processes.
Manage and order laboratory and equipment consumables.
Coordinate off-site testing studies, including sample collection, shipping, and purchase order requisition.
Draft/revise Quality/Sterility Assurance procedures with sterility assurance team support.
Suggests and documents process changes to support projects and process improvements.
Liaise with quality assurance, engineering and development groups for all environmental monitoring and lab testing issues.
Willingness to work as part of a team, contributing ideas to improve processes.
Willingness to expand knowledge base in support of team's primary functions.
Other duties as assigned to support environmental monitoring, product cleaning, product testing, and sterilization.
3. Educational Level and Special Training Required
High School or equivalent; associates degree or college level biology and chemistry course work preferred.
4. Work Experience Required
Minimum one-year experience working in a regulated environment. (Waived if attained an Associate degree or higher)
5. Qualifications and Skills
Excellent oral and written communications skills.
Ability to work independently with little direction.
Ability to follow and meet schedules and timelines.
Ability to work varied schedules and overtime hours as necessary.
Understand and follows QSR, ISO, and departmental procedures.
Experience in Microsoft Office (word, excel, etc.).
6. Physical Requirements
Work Environment:
Exposure to a medically controlled environment, subject to interruptions, subject to changing conditions.
Protective Personal Equipment required as indicated by area procedure.
Physical Requirements: prolonged standing, sitting, and/or walking. This position may also require: hands to finger motion, handling, reaching with hands and arms, balance, stooping, kneeling, or crouching.
Medium Work: Will occasionally need to lift and/or move up to 30 pounds (see assistance for greater amounts)
Visual Demands:
Near acuity, ability to see at 20 inches or more, distance vision, peripheral vision, depth perception, and the ability to adjust focus.
Travel Percentage: None
