QA LAB TECHNICIAN II

Job Description

Job Description

General Position Summary Quality Assurance Lab Technician II

Responsible for providing support in the identification, development and deployment of specifications, special controls, tests, inspections, validations, and verifications, necessary to assure the quality of the Company's products.

Analyzes raw and in-process materials and final products utilizing IHC, ISH, PCR technology as well as molecular / biochemical assays.

Applies basic laboratory skills and techniques to analyze test results. Prepares technical summaries and investigates customer complaints.

Essential Job Functions

Quality Support Activities

Actively participates in the maintenance and improvement of the company’s Quality / Business System with the ownership of job specific processes and participation of related processes and teams.

Purchase Order Review

Provides support to assure compliance of products received to products ordered.

Supplier Qualification

Supports Materials Management in the evaluation, selection, monitoring and measurement of supplier quality.

Technical Operation Activities

• Analyzes raw, in-process materials and finalized products using IHC, ISH, ELISA and molecular / biochemical techniques.
• Analyzes and interprets test results according to established quality control guidelines.
• Inspects in-process and final products.
• Monitors various quality control equipment parameters to ensure proper calibration and operation.
• Maintains laboratory instruments and facilities in good working condition.
• Executes and completes validation protocols for processes and test equipment.
• Notifies management of any and all issues that may affect product quality.
• Cleans lab area and biosafety cabinets.
• Maintain QC retention area and samples.
• Communicate with Production Management in order to schedule activities to meet customer orders and maintain proper inventory levels.
• Assist with the inspection of incoming and in-process inspection of components and finished goods for all company products.

Information Management & Reporting Activities

• Performs data analysis.
• Provides feedback by preparing charts, graphs, reports and other methods of communication as to how well the Quality System is working.

Other Activities

• Provides support in review, analysis and input to Specifications, DCO's, ECO's, Technical Manuals, Bulletins, Advertisements, and etc.
• Process Proving. Participates in Engineering Tryouts and Cut-ins. Assists in the identification and development of special controls, test and skill requirements necessary for assuring product quality.

Aids in the development and documentation of inspection check points and methods. Provides support relating to reliability of design, and usability.

• Process Control. Provides support in initiation, audits and verifications of compliance of processes prior to first product acceptance.
• Assists in field failures analysis, and corrective action. Provides liaison to Product Support and Technical Services Departments.
• Training. Assists in training programs to insure that personnel who may impact product quality are qualified to perform their special functions.

Assist in training newly hired colleagues in quality area.

Document and Maintain. Document and control nonconforming product via MRB logs. Maintain lab supplies to meet production demands.

Essential Job Requirements

Education

BS or BA degree in Biological Sciences, Biochemistry or equivalent combination of education and experience. Additional course work in quality and quantitative methods a plus.

Previous system / process auditing a plus.

Experience & Minimum Qualifications

• 3 - 5 years of related experience or equivalent combination of education and experience.
• Previous GMP / GLP experience.
• Ability to work independently and effectively troubleshoot.
• Ability to adapt to constant changes and work effectively under pressure and time constraints.
• Ability to deal with problems involving product failure, analysis and remedial actions with minimum supervision.
• Effective communication skills. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Excellent mathematical skills. Ability to apply advanced mathematical concepts such as exponents, logarithms, and quadratic equations.
• Knowledge of biochemical processes including : Spectrophotometry, Bacterial Culture, Chromatography, PCR, Probe and In situ hybridization, Antibody and Immunohistochemistry (IHC), Mammalian cell culture, DNA and RNA, Cell Blocks.
• Ability to effectively interact with diverse personalities. Must be tactful and flexible.
• Possesses excellent communication skills with department personnel, management and suppliers.

Physical Requirements & Working Environment

• May be required to occasionally lift, carry, push, or pull up to 50 pounds with assistance.
• This position frequently works in a laboratory environment.
• Ability to work safely and proficiently in a shop environment with a variety of instruments and tools.
• Ability to travel to other locations both within and outside of the local region.
• Ability to read and analyze hard written copy and information on a computer screen.

Physical Requirements & Working Environment (continued)

• Ability to successfully respond to multiple work pressures.
• Ability to listen, resolve problems, and manage tasks.
• Ability to effectively communicate verbally and in writing to individuals and groups.
• Ability to meet multiple deadlines and work under time constraints.
• Ability to effectively interact with diverse personalities. Must be tactful and flexible.
• Must be able to manage change effectively.
• This position requires the employee to frequently sit. In addition, the employee is occasionally required to stand, walk, use hands and fingers and reach with hands and arms.

Sakura Finetek USA, Inc. is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

The above description identifies the essential job functions and skills needed by the person or persons assigned to this position.

These job functions and skills are not intended to be a complete and exhaustive list of all responsibilities, duties and skills required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information contained herein is subject to change at the company's discretion.