What are the responsibilities and job description for the QA Facilities Specialist/Risk Assessor (Temp to Perm) position at Accordance Search Group?
Job Summary:
Works with engineering, manufacturing, research and development, device development, and regulatory affairs to provide professional quality guidance to assess, correct, and maintain the product and process quality from a validation perspective using statistical tools, documented methods, experimental designs and sampling plans. Provide technical advice to the site leadership team on quality, reliability, safety and performance issues encountered during product life cycle.
Provide technical support to project teams. Interface with functional areas in such areas as preparing test plans, data analysis, specifications, risk analysis, change implementation and process validation.This position is contract for 3 to 6 months, possible Contract to Hire.
Essential duties and key job responsibilities and essential functions.
- Support Engineering groups with generating, executing and reviews of master and completing qualification and validation protocols; and summary reports
- Ensures qualification and validation studies are conducted according to approved protocols and SOPs
- Identify, communicate and escalate complex technical issues. Identify options for resolutions and lead implementation of corrective actions.
- Review complex qualification and validations, review documents for content and compliance
- Review calibration criticality assessments for complex systems
- Review development/clinical documents
- Basic knowledge of risk assessments (DFMEA, FMEA, etc.), participate in risk assessments
- Identify, communicate and escalate compliance issues and identify options for resolution, Identify and benchmark compliance best practices.
- Comprehend and interpret regulatory and quality standards
- Perform and execute records in electronic systems, administer electronic systems and transfer knowledge to others
- Manage projects of medium scope (multiple departments/low risk)
- Works independently or with minimal guidance from management on priorities
- Responsible for observing all Company, Health, Safety and Environmental guidelines.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485/9001, European requirements, etc.)
Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- BA/BS in a scientific or technical discipline with 4-6 years' experience in a GxP environment or MS with 2-4 years or the equivalent combination of experience and training. (AA/AS, 10 years' experience in a GxP environment)
- Former Chemist or Scientist background preferred
- Proficiency in MS Word, Excel, and PowerPoint.
- Good writing skills - must be able to author Validation Program documentation, SOPs and other similar documents
- Detail orientated
SKILLS AND CERTIFICATIONS[note: bold skills and certification are required]
Quality Assurance
SOP
Risk Assessor
Validation and Qualification Protocols
Compliance