TalentZök

Receive alerts when this company posts new jobs.

QA Specialist

at TalentZök

Posted: 11/1/2017
Job Status: Full Time
Job Reference #: 7864

Job Description

QA Specialist (MolecularDx) – Simply Biotech   (7864)
OVERVIEW
Are you looking for a new career opportunity with a well-established commercial stage molecular diagnostics company with a high complexity genetic testing CLIA certified laboratory specializing in the field of pharmacogenetics, or PGx?! Our client has proprietary gene expression profiles that include assays for differential diagnosis of pediatric cancers and for improved diagnosis and management of prostate cancer!
 
Immediate opening for a QA Specialist in San Diego, CA who possesses:
  • +/-2 years relevant experience in quality assurance working in a cGMP or CLIA regulatory environment
  • Experience with MasterControl software for document control and training modules (this is key)
  • Detail oriented and strong written and verbal communication skills.
 
Email resume to mturner@simplybiotech.com and call 858.356.6772.
 
FULL DESCRIPTION:
  • As part of the Quality team, monitor the compliance of quality systems to CLIA regulations, CAP accreditation standards, HIPAA, and company’s Compliance Program requirements.
  • Manage MasterControl activities for document control and training modules.
  • Maintain quality records, systems, and procedures.
  • Coordinate and conduct quality system and compliance audits.
  • Collaborate with Revenue Cycle personnel to review federal and private payor audit requests and associated documentation for compliance to requirements.
  • Evaluate audit findings and provide support to area management in implementing appropriate preventive/corrective actions as required. Monitor actions taken for effectiveness.
  • Support company training system activities including providing quality management system training. Maintain and file training documentation.
  • Support materials management activities such as review of material specification sheets and approval of compliant materials for release.
  • Provide support for deviation and CAPA root cause analysis and closeout activities. Use quality tools to assist with root cause analysis.
  • Ensure change is managed in accordance to the change control system.
 
The ideal QA Specialist shall possess the following:
  • +/-2 years relevant experience in quality assurance working in a cGMP or CLIA regulatory environment
  • Experience with MasterControl software for document control and training modules (this is key!)
  • Ability to manage multiple projects
  • Detail oriented and strong written and verbal communication skills.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • Demonstrated ability to follow detailed directions in a laboratory environment.
  • Must be familiar with Microsoft Office applications.
 
For immediate and confidential consideration, please email your resume to mturner@simplybiotech.com and call 858.356.6772