What are the responsibilities and job description for the Quality Control Inspector position at KYYBA?
Essential Duties and Responsibilities
- Conduct product testing, including testing to support complaint investigations and stability verification
- Generate product testing results reports
- Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
- Conduct spot-check inspections/audits of production operations
- Participate in the internal audit program
- Write, review and approve Standard Operating Procedures (SOPs) as necessary
- May assist in supporting the Document Control program, record retention areas, and sample retention areas
- May support returned instrument processing
o Log returned instruments from the field.
o Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
o Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing.
o As necessary, process instrument documentation for return to repair facility, and pack instruments as required.
Required:
- High school diploma or equivalent qualification.
- 1 years’ experience working in manufacturing, or related field. Excellent knowledge of MS Office and Excel. Good math and technical skills.
- Working knowledge of quality control standards, and when necessary testing techniques as well.
- Positive and cooperative communication, both verbal and written, and effective collaboration with all levels of employees, customers, contractors, and vendors.
- Working knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulator requirements. Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as high level of attention to detail and accuracy. Ability to maintain regular and predictable attendance.
- Must be an effective team player with the ability to train other technicians.
Salary : $25 - $28
