3467 Laboratory Technical Specialist
Description:
The Laboratory Technical Specialist will perform Physical and Analytical testing of medical devices and combination products for R&D, verification, complaints, and stability programs.
He or she will perform laboratory testing in a cGMP environment and understand the technical and compliance needs of the business, as well as actively participate in continuous improvement to maintain company’s right to operate, supply to patients and cost effectiveness.
Primary technologies include implants, auto-injectors, patch pumps, needle systems, and pre-filled syringes.
Job Responsibilities:
Leadership:
Create an environment of strong team spirit with timely and effective communications.
Develop ability to influence using technical and personal reasoning.
Technical:
Perform a broad variety of basic, moderate, and complex tests in support of lab operations, design verification, test method validation, R&D characterization, and complaints investigation.
Perform testing of routine and non-routine samples and documents according to cGMPs.
Perform routine lab maintenance.
Prepare basic and complex reagents as assigned.
Order and maintain lab supply inventory.
Perform sample filling and decontamination, and assist in lab complaints investigations.
Receive and provide training.
Participate in method transfer and validation.
Perform equipment qualification/maintenance as assigned.
Coordinate with lab supervisor to support operational activities.
Identify and support resolution of technical problems.
Actively participate in group and project teamwork; project and process improvements.
Resolve issues as needed with management approval.
Adhere to cGMP policies and procedures, including documentation activities.
Meets scheduled performance of at least 95% on time.
Perform other duties as requested by supervisor/manager to support Quality.
Education and Experience:
B.S./B.A. (preferably in relevant scientific discipline) or an equivalent combination of education and experience.
Technical Knowledge:
Basic knowledge of scientific theories, principles, and techniques used in physical and analytical test procedures.
Ability to exercise sound judgement, reasoning and problem solving.
Capable of completing assigned responsibilities and keeping manager informed of status.
Extensive knowledge and technical understanding to complete routine and non-routine assignments.
Good verbal and written communication skills needed to accomplish assigned tasks.
Ability to work under minimal supervision to complete assigned tasks in a timely manner.
Interpersonal Skills:
Must be highly organized, analytical, detail oriented and able to conduct work independently.
Able to conduct work on multiple projects with precision.
Team oriented, creative, eager to take on responsibility.
Excellent written and verbal communication skills are required.
Demonstrated ability to communicate with internal stakeholders and external collaborators.
Work Environment / Physical Demands Considerations:
The majority of work is completed at the location of employment in a laboratory type setting.
Ability to make repetitive motions and manual manipulations of samples.
Must be able to lift 25 pounds.
Safety Considerations:
Work is performed in a laboratory setting.
Work requires use of glassware, needles, and syringes.
PPE (e.g. lab coat, safety glasses) are required whenever working in the laboratory.
Compensation range: $35 to $43.50/hr