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Conducts testing, executes protocols, analyzes data, and verifies QC critical control points with its applicable specifications, inspection and testing mechanisms and equipment. Interfaces with Manufacturing, Quality Control, Quality Assurance, Quality Engineering, and Supply Chain/Materials Management within the company.
(other duties may be assigned for R&D, Quality, and Operations):
- Conducts QC testing, execute protocols, analyze data
- Suggests improvements to revise QC procedures
- Helps develop QC procedures and participates on assigned CAPA teams,.
- Verifies the effectiveness of critical QC checkpoints for system, assembly and component manufacturing.
- Tests production and prototype products
- Follows good documentation practices to comply with ISO standards and FDA QSR requirements.
- Support complaint investigations with QA, QE, and Technical Services
- Conduct environmental monitoring and contamination control testing
None
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required to be trained. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Technical knowledge of molecular biology, including principles of nucleic acid hybridization, probe and primer design, molecular cloning and enzymatic amplification of specific gene sequences.
- Strong experience in lab techniques such as PCR, DNA hybridization assays, Capillary electrophoresis and UV absorbance measurements.
- Strong pipetting, precision reagent formulation and analytical testing skills are required
- Experience in testing
- Training and experience in basic statistical analysis tools preferred.
- Ability to work in a multi-functional team environment.
- Ability to work under schedule/milestone pressures including overtime when requested by management.
- Ability to understand and apply scientific concepts and Good Laboratory Practices as trained.
- Demonstrated ability to be flexible and resourceful.
- Good communication skills.
- Knowledge of safety precautions required for working with biohazards and blood borne pathogens after training
A.A.S or B.S. degree minimum; and 3 or more years of relevant experience as a QC technician in molecular biology, biochemistry, or a related field. In rare occasions, a highly qualified and experienced individual with additional years of relevant experience may fulfill the degree requirement.
Proficient in writing, and communicating in the English language.
Must be consistent with college level education. Knowledge of basic statistics relevant to interpretation and analysis of scientific data required.
Consistent with education and experience requirements.
ASQ Certification as CQT,preferred.
The physical demands described here 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.
Work entails regularly performing tasks while working at a computer, desk, and laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
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.
This position will involve a combination of biotechnology laboratory, manufacturing, and office environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood Bourne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
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