Quality - Lab Technician II - Non-Exempt

Job Description

Job Description

HM's Top Needs:

1. Ability to document accurately and in real time.
2. Ability to follow test methods and procedures.
3. Professional demeanor and ability to work in a high throughput laboratory.
   
   

   40 hours per week.

   Brooklyn Center North Building location.

   Required full time onsite.

Position Description

The Laboratory Technician works with scientists, engineers, and technicians supporting quality control, product support & development testing. The technician will perform sample preparation and analysis as part of a laboratory team. The technician will review, authorize and report results, support document creation and revision, and participate in continuous improvement projects for the lab. The role functions as part of the Analytical Laboratory that works under ISO17025 requirements in the medical device field.

Position Responsibilities

Support sample registration, labeling, traceability, and storage.

Perform sample preparation including:

o Sectioning with trim saw and automated mill

o Mounting using various medias

o Grinding and Polishing using Abrapol and Tegramin grinders

o Surface etching with Acids

Use a microscope as an analysis tool for dimensional measurement and evaluation of surface features

Equipment set up, cleaning, troubleshooting, calibration, and operation

Real time documentation of test protocols and data collection

Author and review laboratory processes

Assist engineers and scientist in equipment and process qualifications

Participate in and or lead continuous improvement projects

Perform general support including preparing chemical solutions and maintaining inventory of consumable supplies

Perform work in adherence to procedures, department policies and regulatory requirements

Basic Qualifications

0-2 years related experience in technical areas such as in metallurgical, electronic, mechanical or related technical discipline.

Good written and verbal communication skills to interface effectively with clients, laboratory personnel, and other functions

Proficient with Microsoft Office programs including Microsoft Outlook, Word and Excel

Must be self-motivated, detail-oriented and able to work in a fast-paced team environment

Ability to prioritize and execute on daily tasks

Ability to work and be effective with minimal supervision

Desired/Preferred Qualifications

A successful candidate will have experience working in a laboratory setting. Preferred qualifications include:

• 2-year technical degree in metallurgical, electronic, mechanical or related technical discipline.
• Experience working in and documenting experiments in a highly regulated environment.

Experience with Laboratory Information Management System (LIMS)

Experience with continuous improvement tools such as, Lean Sigma or Six Sigma.

• Experience and understanding of cGMP, ISO17025, FDA and ICH requirements.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required to be able to stand / sit / walk 8 hrs per day or possible extended periods of time doing laboratory work.

Responsibilities may include the following and other duties may be assigned. Performs a variety of technical procedures such as preparing routine solutions and reagents and performing routine reactions. Makes and records observations; performs simple calculations; and collects and prepares data for evaluation. Conducts laboratory support functions such as stocking and distributing supplies and equipment; arranging and dismantling apparatus; and collecting, washing, and storing glassware. Performs technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements. May analyze compounds and manage corporate compound collection. Performs technical procedures in one or more of the following areas: Production, Research and Development, Quality Control/Assurance, and/or Compliance/Environmental. TECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes. DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor, working under moderate supervision . Performs tests, interprets data and develops reports. Organizational Impact: Performs intermediate technical activities requiring judgment and decisionmaking . Work consists of technical tasks that are typically routine. Innovation and Complexity: Technical problems faced are generally routine, but may require interpretation of procedures or policies to resolve problems . May be required to highlight areas of concerns/problems in own job area. Communication and Influence: Communicates typically with internal contacts . Obtains and provides technical information requiring some explanation or interpretation . Leadership and Talent Management: May provide guidance and assistance to new or entry level employees. Required Knowledge and Experience: Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.